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Beckman Coulter Inc. - AU2700 and AU5400 Clinical Chemistry Analyzers - Class 2 Recall
AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body fluids, including whole blood. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 29, 2013 Category: Medical Equipment Source Type: alerts

Beckman Coulter Inc. - AU5800 Clinical Chemistry Analyzer - Class 2 Recall
AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, and in selective electrode. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 24, 2013 Category: Medical Equipment Source Type: alerts

Ortho-Clinical Diagnostics - VITROS Chemistry Products PHBR Slides - Class 2 Recall
VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 19, 2013 Category: Medical Equipment Source Type: alerts

Abbott Laboratories, Inc - Clinical Chemistry Phenobarbital - Class 2 Recall
Clinical Chemistry Phenobarbital, list number 1E08 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 15, 2013 Category: Medical Equipment Source Type: alerts

Ortho-Clinical Diagnostics - VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Chemistry System Refurbished - Class 2 Recall
VITROS 5,1 FS Chemistry System, Product Code 6801375 and VITROS 5,1 FS Chemistry System Refurbished, Product Code 6801890. Intended for use in the measurement of a variety of chemistry analytes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 13, 2013 Category: Medical Equipment Source Type: alerts

Ortho-Clinical Diagnostics - VITROS 4600 Chemistry System - Class 2 Recall
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code 6802445. Intended for use in the measurement of a variety of chemistry analytes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 13, 2013 Category: Medical Equipment Source Type: alerts

Ortho-Clinical Diagnostics - VITROS 5600 Integrated System - Class 2 Recall
VITROS 5600 Integrated System, Product Code 6802413. Intended for use in the measurement of a variety of chemistry analytes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 13, 2013 Category: Medical Equipment Source Type: alerts

Becton Dickinson & Company - BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube - Class 3 Recall
BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 ml, 13 X 75 mm STERILE REF 364953. Becton Dickinson & Company, Franklin Lakes, NJ USA, The kit consists of a transfer straw and urinalysis tube intended for UA chemistry urine testing. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2013 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) - Class 2 Recall
Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) The Phosphorus (PHOS) method used on the Dimension(R) clinical chemistry system is an in vitro diagnostic test intended for the quantitative measurement of phosphorus in human serum, plasma, and urine. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 2, 2013 Category: Medical Equipment Source Type: alerts

Abbott Laboratories, Inc - ARCHITECT HBsAg Qualitative Assay, ARCHITECT HBsAg Qualitative Confirmatory Assay - Class 2 Recall
ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number 4P54 The ARCHITECT HBsAg Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma and neonate serum. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 25, 2013 Category: Medical Equipment Source Type: alerts

Mindray DS USA, Inc. d.b.a. Mindray North America - BS200 Chemistry Analyzer - Class 2 Recall
BS-200 Chemistry Analyzer Designed for clinical laboratory use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 22, 2013 Category: Medical Equipment Source Type: alerts

Hitachi Chemical Diagnostics Inc - OPTIGEN Food 30 - Class 3 Recall
OPTIGEN Food 30; Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France Allergen testing (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 7, 2013 Category: Medical Equipment Source Type: alerts

Ortho-Clinical Diagnostics - VITROS Chemistry Products Vapor Adsorption Cartridge - Class 2 Recall
Ortho Clinical Diagnostics VITROS¿ Chemistry Products Vapor Adsorption Cartridge REF/CAT No. 680 0100. VITROS¿ Vapor Adsorption Cartridges are used to remove vapor contaminants that may potentially interfere with Signal Reagent used with MicroWell Assays on the VITROS¿ 3600, VITROS¿ 5600, and VITROS¿ ECi/ECiQ Systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 30, 2013 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - Siemens Dimension(R) IRON Calibrator (DC85) - Class 3 Recall
Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R) IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the Iron method for the Dimension(R) clinical chemistry system. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 29, 2013 Category: Medical Equipment Source Type: alerts

Alfa Wassermann, Inc. - Alfa Wassermann System Diluent 750 mL - Class 2 Recall
Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006 Alfa Wassermann B.V. Pompmolenlaan 24 3447 GK, Woerden The Netherlands Common name is water solution. Intended to dilute reagents and rinse the parts of a clinical chemistry instrument. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 28, 2013 Category: Medical Equipment Source Type: alerts

Abbott Laboratories - ARCHITECT 25OH Vitamin D Reagent Kit - Class 2 Recall
ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x 100 tests), 03L52-35 (ROW) and 03L52-37 (U.S.) (5 x 100 tests); Abbott Laboratories, Abbott Park, IL 60064 USA, Abbott, Max-Planck-Ring 2, 65205 Wiesbaden, Germany, product of Spain; Product Usage:The ARCHITECT 25-OH Vitamin D assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 25-hydroxyvitamin D (25-OH vitamin D) in human serum and plasma. The ARCHITECT 25-OH Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 23, 2013 Category: Medical Equipment Source Type: alerts

Roche Diagnostics Operations, Inc. - Roche COBAS INTEGRA 400 and 400 plus Analyzer - Class 3 Recall
Roche COBAS INTEGRA 400 and 400 plus Analyzer The Roche COBAS INTEGRA 400/400 plus Analyzer is a fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 18, 2013 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics Inc - Siemens ChekStix Combo Pak - Class 2 Recall
Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 4, 2013 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics Inc - Siemens ChekStix Combo Pak - Class 3 Recall
Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 4, 2013 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics Inc - Siemens ChekStix Positive and Negative Control Strips for Urine Chemistry - Class 3 Recall
Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (Distributed OUS Only) Catalog Number: 1360L Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 4, 2013 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics Inc - Siemens ChekStix Combo Pak - Class 3 Recall
Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 4, 2013 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics Inc - Siemens ChekStix Positive and Negative Control Strips - Class 3 Recall
Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Catalog Number:1360 Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 4, 2013 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics Inc - Siemens ChekStix Combo Pak - Class 3 Recall
Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 4, 2013 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics Inc - Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine - Class 3 Recall
Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Number: 5019 When used with the CLINITEK ATLAS¿ Automated urine Chemistry Analyzer and CLINITEK ATLAS¿ 10 reagent Pak, CLINITEK ATLAS¿ Positive and Negative Control Strips provide defined results for color, clarity, glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrite, and leukocytes. Each CLINITEK ATLAS Positive Control Strip is a firm plastic strip to which are affixed seven separate analyte areas. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 4, 2013 Category: Medical Equipment Source Type: alerts

Horiba Instruments, Inc dba Horiba Medical - PENTRA C200 - Class 2 Recall
PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro diagnostic analyses based on homogeneous samples such as serum, plasma and uring. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 3, 2013 Category: Medical Equipment Source Type: alerts

Beckman Coulter Inc. - Access Immunoassay System - Class 2 Recall
Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel DxC 600i Synchron Access Clinical System Part Numbers: Access 81600; Access 2 81600N, 386220, A69186, A25656, A12900; Access 2 (LXi) A15642; Access 2 Section, DxC 600i A25640. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The Synchron LXi and the UniCel DxC 600i are Access systems integrated with a chemistry analyzer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 22, 2012 Category: Medical Equipment Source Type: alerts

Beckman Coulter Inc. - Access hLH Calibrators - Class 2 Recall
The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems. The Access hLH Calibrators are intended to calibrate the Access hLH assay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 20, 2012 Category: Medical Equipment Source Type: alerts

Roche Molecular Systems, Inc. - Instrument Manager - Class 2 Recall
DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 7, 2012 Category: Medical Equipment Source Type: alerts

Roche Molecular Systems, Inc. - cobas Integra 400/400 Plus - Class 2 Recall
cobas¿ Integra 400/400 Plus (Software version 3.4) The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 7, 2012 Category: Medical Equipment Source Type: alerts

Roche Diagnostics Operations, Inc. - Cobas 8000 Modular Analyzer Series - Class 2 Recall
Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 4, 2012 Category: Medical Equipment Source Type: alerts

Beckman Coulter Inc. - UniCel Dxl 600 Access Immunoassay System - Class 2 Recall
UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 19, 2012 Category: Medical Equipment Source Type: alerts

Beckman Coulter Inc. - UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems - Class 2 Recall
UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, Part Numbers: A64871, A64903, A64935, A59102. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 19, 2012 Category: Medical Equipment Source Type: alerts

Beckman Coulter Inc. - UniCel Dxl 800 Access Immunoassay System - Class 2 Recall
UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 19, 2012 Category: Medical Equipment Source Type: alerts

Horiba Instruments, Inc dba Horiba Medical - ABX PENTRA Creatinine 120 CP - Class 3 Recall
ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709. The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). It is composed of a 27 ml monoreagent cassette. Reagent is a chemical solution with additives. ABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine ba...
Source: Medical Device Recalls - November 14, 2012 Category: Medical Equipment Source Type: alerts

Beckman Coulter Inc. - UniCel DxC 600/800 with - Class 2 Recall
UniCel¿ DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel¿ DxC Synchron¿ Clinical Systems are fully automated, computercontrolled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent). (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 24, 2012 Category: Medical Equipment Source Type: alerts

Beckman Coulter Inc. - UniCel Closed Tube Aliquotter for UniCel DxC 660i, 680i, 860i and 880i Synchron Access Clinical Sys - Class 2 Recall
Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel DxC 880i Synchron Access Clinical Systems. Part Number A45853. Product Usage: The UniCel DxC Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in-vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent). (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 12, 2012 Category: Medical Equipment Source Type: alerts

Beckman Coulter Inc. - Access Folate Calibrators - Class 2 Recall
Access Folate Calibrators, Part Number: A14207. The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) or red blood cells using the Access Immunoassay Systems. The serum folate level is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 10, 2012 Category: Medical Equipment Source Type: alerts

Steris Corporation - Verify BowieDick Test Card - Class 2 Recall
Verify¿ Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 9325 Pinecone Drive, Mentor, OH 44060 The Verify Bowie-Dick Test Card consists of a card printed on one side with bars of chemical indicator ink. On the opposite side of the card, space is provided for critical cycle information to be recorded. The card is laminated inside a thin clear plastic enclosure. The enclosure has two holes in it to allow air removal and steam penetration. The preassembled test is used to evaluate the effectiveness of air removal from the sterilizer chamber during prevacuum pulse steam sterilizer cycle. Following a prev...
Source: Medical Device Recalls - September 20, 2012 Category: Medical Equipment Source Type: alerts

Steris Corporation - The SYSTEM 1E Liquid Sterilant Processing System. - Class 2 Recall
The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 7, 2012 Category: Medical Equipment Source Type: alerts

Steris Corporation - QKC1692E - Class 2 Recall
QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 28, 2012 Category: Medical Equipment Source Type: alerts

Ortho-Clinical Diagnostics - VITROS Chemistry Products Digoxin (DGXN) Slides - Class 2 Recall
VITROS Chemistry Products DGXN Slides --- [REF] 834 3386. Product is packaged in a box with multiple slides. The lot and expiration codes are found on the side of the package. Product Usage: Intended use: For in vitro diagnostic use only. VITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 15, 2012 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - Dimension(R) Reagent Management System (RMS) Power Cord. - Class 2 Recall
Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens Healthcare Diagnostics Dimension(R) clinical chemistry analyzers are floor model, fully automated, microprocessor-controlled, integrated instrument systems that use prepackaged Flex(R) reagent test cartridges to measure a variety of analytes in human body fluids. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 9, 2012 Category: Medical Equipment Source Type: alerts

Iris Diagnostics - IRISpec CA/CB twopart urine chemistry control twin set - Class 3 Recall
IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 1, 2012 Category: Medical Equipment Source Type: alerts

Ortho-Clinical Diagnostics - VITROS 4600 Chemistry System Software - Class 2 Recall
VITROS 4600 Chemistry System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 23, 2012 Category: Medical Equipment Source Type: alerts

Alere San Diego, Inc. - Alere Triage ToxMTD Drug Screen - Class 2 Recall
Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or...
Source: Medical Device Recalls - July 19, 2012 Category: Medical Equipment Source Type: alerts

Abbott Point Of Care Inc. - Military Kit Portable Clinical Analyzer - Class 2 Recall
Military Kit Portable Clinical Analyzer ; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K ...
Source: Medical Device Recalls - July 9, 2012 Category: Medical Equipment Source Type: alerts

Abbott Point Of Care Inc. - Fuso Analyzer 300F - Class 2 Recall
Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K 001387 (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 9, 2012 Category: Medical Equipment Source Type: alerts

Abbott Point Of Care Inc. - iStat1 Analyzer - Class 2 Recall
iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 9, 2012 Category: Medical Equipment Source Type: alerts

Abbott Point Of Care Inc. - iSTAT1 Abaxis Analyzer - Class 2 Recall
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K 001387 (Source: M...
Source: Medical Device Recalls - July 9, 2012 Category: Medical Equipment Source Type: alerts

Abbott Point Of Care Inc. - iStat Portable Clinical Analyzer; - Class 2 Recall
i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K 001387 ...
Source: Medical Device Recalls - July 9, 2012 Category: Medical Equipment Source Type: alerts