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ConMed Corporation - WANG Transbronchial Aspiration Needles - Class 2 Recall
WANG Transbronchial Aspiration Needles Cat. No. MW-221, WANG Cytology Needles, Central or Peripheral Regions, 21 g x 15 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use with a bronchoscope. They are used to puncture the tracheobronchial wall and to aspirate sufficient tissue and/or cell specimens to stage bronchogenic carcinoma. These are disposable sterile, single-use devices. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 10, 2012 Category: Medical Equipment Source Type: alerts

ConMed Corporation - WANG Transbronchial Aspiration Needles - Class 2 Recall
WANG Transbronchial Aspiration Needles Cat. No. MW-322, WANG Cytology Needles, Central, Mediastinal and Hilar Regions, 22 g x 13 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use with a bronchoscope. They are used to puncture the tracheobronchial wall and to aspirate sufficient tissue and/or cell specimens to stage bronchogenic carcinoma. These are disposable sterile, single-use devices. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 10, 2012 Category: Medical Equipment Source Type: alerts

ConMed Corporation - WANG Transbronchial Aspiration Needles - Class 2 Recall
WANG Transbronchial Aspiration Needles Cat. No. MW-222, WANG Cytology Needles, Central or Peripheral Regions, 22 g x 13 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use with a bronchoscope. They are used to puncture the tracheobronchial wall and to aspirate sufficient tissue and/or cell specimens to stage bronchogenic carcinoma. These are disposable sterile, single-use devices. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 10, 2012 Category: Medical Equipment Source Type: alerts

ConMed Corporation - WANG Transbronchial Aspiration Needles - Class 2 Recall
WANG Transbronchial Aspiration Needles Cat. No. SW-121, WANG Cytology Needles, Central, Carinal and Mediastinal Regions, 21 g x 15 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use with a bronchoscope. They are used to puncture the tracheobronchial wall and to aspirate sufficient tissue and/or cell specimens to stage bronchogenic carcinoma. These are disposable sterile, single-use devices. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 10, 2012 Category: Medical Equipment Source Type: alerts

US Endoscopy Group Inc - Infinity sampling device, Cytology Brush - Class 2 Recall
Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The Infinity sampling device is a disposable cytology brush used to retrieve cytological cell samples in the gastrointestinal tract. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 17, 2012 Category: Medical Equipment Source Type: alerts

Tripath Imaging, Inc. - PrepStain System - Class 2 Recall
PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671); PrepStain Prep Only PM Kit, T-AG (Catalog 490954); PrepStain PM Kit XLP, T-US-II (Catalog 490424); PrepStain Prep PM Kit XLP T-US-II (Catalog 491118); PrepStain Prep Only PM Kit XLP, T-US-II (490423); PrepStain Prep Only PM Kit, T-US (Catalog 490429); PrepStain PM Kit, T-US (Catalog 490626); PrepStain PM Kit Europe, T-US (Catalog 490428). The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-ca...
Source: Medical Device Recalls - July 26, 2012 Category: Medical Equipment Source Type: alerts

Tripath Imaging, Inc. - PrepStain System - Class 2 Recall
PrepStain Slide Processor. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytology Diagnoses. The 1.2 DiTi is the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 26, 2012 Category: Medical Equipment Source Type: alerts

Tripath Imaging, Inc. - PrepStain System - Class 2 Recall
PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytology Diagnoses. The 1.2 DiTi is the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 26, 2012 Category: Medical Equipment Source Type: alerts

Tripath Imaging, Inc. - PrepStain System - Class 2 Recall
PrepStain Kit: 1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytology Diagnoses. The 1.2 DiTi is the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 26, 2012 Category: Medical Equipment Source Type: alerts

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall
BD FocalPoint"120V / 11 FOV under 5%, Catalog number: 490652 The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 21, 2012 Category: Medical Equipment Source Type: alerts

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall
BD FocalPoint"230V / 11 FOV under 5%, Catalog number: 490648. The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 21, 2012 Category: Medical Equipment Source Type: alerts

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall
BD FocalPoint"230V / 11 FOV (Refurbished), Catalog number: 490649. The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 21, 2012 Category: Medical Equipment Source Type: alerts

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall
BD FocalPoint"100V / 15 FOV under 5%, Catalog number: (Refurbished) 490365 The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 21, 2012 Category: Medical Equipment Source Type: alerts

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall
BD FocalPoint"120V / 15 FOV (Refurbished), Catalog number: 490398. The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 21, 2012 Category: Medical Equipment Source Type: alerts

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall
BD FocalPoint"230V / 15 FOV under 5%, Catalog number: 490137. The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 21, 2012 Category: Medical Equipment Source Type: alerts

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall
BD FocalPoint"230V LC (Refurbished), Catalog number: 490681. The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 21, 2012 Category: Medical Equipment Source Type: alerts

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall
BD FocalPoint"120V / 11 FOV (Refurbished), Catalog number: 490653. The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 21, 2012 Category: Medical Equipment Source Type: alerts

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall
BD FocalPoint"100V / 15 FOV under 5%, Catalog number: 490364 The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 21, 2012 Category: Medical Equipment Source Type: alerts

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall
BD FocalPoint"120v / 15 FOV under 5%, Catalog number: 490397. The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 21, 2012 Category: Medical Equipment Source Type: alerts

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall
BD FocalPoint"100V, Catalog number: 490650 The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 21, 2012 Category: Medical Equipment Source Type: alerts

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall
BD FocalPoint"230V / 15 FOV (Refurbished), Catalog number: 490138. The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 21, 2012 Category: Medical Equipment Source Type: alerts

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall
BD FocalPoint"100V LC (Refurbished), Catalog number: 490682 The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 21, 2012 Category: Medical Equipment Source Type: alerts

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall
BD FocalPoint"100V (Refurbished), Catalog number: 490651 The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 21, 2012 Category: Medical Equipment Source Type: alerts

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall
BD FocalPoint"120V LC (Refurbished), Catalog number: 490683. The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 21, 2012 Category: Medical Equipment Source Type: alerts

Leica Biosystems Richmond Inc. - Cyto Jar Fixative - Class 3 Recall
Surgipath Cyto Jar Fixative; a 120 mL clear, leakproof container prefilled with 45 mL of preservative containing polyethylene glycol for the convenient collection, fixation and preservation of all cytologic specimens, 50 jars per case; for in vitro diagnostic use only; Leica Biosystems, 5205 Rt. 12, Richmond, IL 60071; Made in USA The Cyto Jar is for the convenient collection, fixation and preservation of all cytologic specimens. The 120 mL clear, leakproof container is prefilled with 45 mL of preservative containing polyethylene glycol. It can be used for rinsing aspiration needles or bronchial brushes and for the direct...
Source: Medical Device Recalls - March 29, 2012 Category: Medical Equipment Source Type: alerts

SCC Soft Computer - SoftPath GUI - Class 2 Recall
SoftPath GUI versions: 4.2.3.3-4.2.3.6 and 4.3.0.5-4.3.0.12. SoftPath is a laboratory information system to be used in a clinical laboratory by knowledgeable, trained, and experienced personnel. SoftPath enables the user to document steps in the receiving and processing of surgical, gynecological, medical cytological, and autopsy case specimens within the Pathology labs, for the purpose of generating Pathology reports for requesting physicians and label creation for identification of specimen/case material. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 2, 2011 Category: Medical Equipment Source Type: alerts

SCC Soft Computer - SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12. - Class 2 Recall
SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12. SoftPath is a laboratory information system to be used in a clinical laboratory by knowledgeable, trained, and experienced personnel. SoftPath enables the user to document steps in the receiving and processing of surgical, gynecological, medical cytological, and autopsy case specimens within the Pathology labs, for the purpose of generating Pathology reports for requesting physicians and label creation for identification of specimen/case material. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 2, 2011 Category: Medical Equipment Source Type: alerts

SCC Soft Computer - SoftPath GUI - Class 2 Recall
SoftPath GUI versions: 3.17.5 to 3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4. SoftPath is a laboratory information system to be used in a clinical laboratory by knowledgeable, trained, and experienced personnel. SoftPath enables the user to document steps in the receiving and processing of surgical, gynecological, medical cytological, and autopsy case specimens within the Pathology labs, for the purpose of generating Pathology reports for requesting physicians and label creation for identification of specimen/case material. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 17, 2011 Category: Medical Equipment Source Type: alerts

Ge Healthcare It - GE Centricity Laboratory Instrument Interface Data Innovations Instrument Manager Software - Class 2 Recall
GE Centricity Laboratory Instrument Interface to Data Innovations Instrument Manager software; GE Healthcare IT Solutions, Barrington, IL 60010. The Centricity Laboratory is designed to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and report processing. The centricity is intended to interface with various lab devices through standard HL7 interfaces to record, report and distrib...
Source: Medical Device Recalls - June 14, 2011 Category: Medical Equipment Source Type: alerts

Ge Healthcare It - GE Centricity Laboratory - Class 2 Recall
GE Centricity Laboratory software; GE Healthcare IT, Barrington, IL 60010. The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. The Centricity Laboratory software is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through...
Source: Medical Device Recalls - February 15, 2011 Category: Medical Equipment Source Type: alerts

Ge Healthcare It - GE Centricity Laboratory Instrument Interface Software - Class 2 Recall
GE Centricity Laboratory Instrument Interface software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 22, 2010 Category: Medical Equipment Source Type: alerts

Becton Dickinson & Co. - CLAY ADAMS¿ Dynac¿ III Centrifuge - Class 3 Recall
CLAY ADAMS¿ Dynac¿ III Centrifuge, 120V, Model Number 420104 DYNAC III is a multi-purpose centrifuge, designed for clinical laboratories performing separations in hematology, chemistry, urinalysis, blood banking, microbiology and cytology. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - March 16, 2010 Category: Medical Equipment Source Type: alerts

Remington Medical Inc. - Chiba Needle Marked - Class 2 Recall
Chiba Needle Marked Model: CNM-2308, Size: 23 GA x 20 CM, Remington Medical, Inc., Alpharetta, GA 30005. General purpose aspiration Cytology Biopsy Needle (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - September 20, 2009 Category: Medical Equipment Source Type: alerts

Abbott Molecular - VP 2000 Processor - Class 3 Recall
VP 2000 Processor; an automated tissue stainer 100 volt - part 30-144100 or list 2J11-60; 117 volt - part 30-144101 or list 2J11-01, and part 30-102832 - processor only; 230 volt - part 30-144102 or list 2J11-04, and part 30-102833 processor only. Designed to automate and standardize slide specimen processing including deparafinization, FISH pretreatment and routine slide staining for the laboratory. The unit is preprogrammed to perform slide pretreatment protocols for FISH assays and can be programmed to perform routine histology/cytology slide staining or routine slide washing according to user requirements. (Source: Me...
Source: Medical Device Recalls since July 07, 2006 - August 30, 2009 Category: Medical Equipment Source Type: alerts

Cook OB/Gyn, Inc. - Tao Brush I.U.M.C. Endometrial Sampler (Tao Brush) - Class 2 Recall
Cook Medical Tao Brush I.U.M.C. Endometrial Cytology/Histology Sampler (Tao Brush), 9.0Fr/26 cm, 3.5 cm, sterile, Cook Ob/Gyn, Spencer, IN; REF J-ES-090500-BL. Used to obtain endometrial samples for both cytology and histology. Intended for one-time use. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - June 16, 2009 Category: Medical Equipment Source Type: alerts

GE Healthcare Integrated IT Solutions - Centricity TriWin Laboratory - Class 2 Recall
Centricity TriWin Laboratory Information System; GE Healthcare Integrated IT Solutions, Barrington, IL 60010 The Centricity TriWin Laboratory product is a laboratory information system. It is designed to facilitate the general clinical, anatomic pathology, and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - May 15, 2009 Category: Medical Equipment Source Type: alerts

Bd Diagnostic Systems Tripath - BD PrepStain System - Class 2 Recall
BD PrepStain System, Model Number: 799-14000-00; Catalog Number: 05CR000021, 05CR00021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 799-14000-00R; Catalog Number: 05CR000021, 05CR000021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 7914000-00R. PrepStain is a liquid-based thin layer cell preparation device for preparation and staining of Prep smear slides from cervical specimens in a liquid based format (gyn use) and of cytology examination slides from non-cervical specimens such as urine and lung lavage. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - March 19, 2009 Category: Medical Equipment Source Type: alerts