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Cholesterol

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Siemens Healthcare Diagnostics, Inc. - Siemens Dimension Vista CHEM 1 CAL - Class 2 Recall
Siemens Dimension Vista¿ CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (UA) methods on the Dimension Vista¿ System. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 1, 2014 Category: Medical Equipment Source Type: alerts

Alere San Diego, Inc. - Alere Cholestech LDX Lipid ProfileGLU Test Cassette - Class 3 Recall
Product Brand Name(s): Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette, Model 10-991. Product Generic Name: Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette. Description of the product: Lipid. Glucose panel Test cassettes. Product packaging: 10 individually pouched cassettes in a labeled kit box. Intended for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides, and/or glucose in whole blood, serum, and plasma. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 23, 2013 Category: Medical Equipment Source Type: alerts

Ortho-Clinical Diagnostics - VITROS Chemistry Products dHDL Slides - Class 2 Recall
VITROS Chemistry Products dHDL Slides packaged as 300 slides/pack catalog number 6801895 VITROS dHDL Slides quantitatively measure HDL cholesterol (HDLC) 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 - November 16, 2013 Category: Medical Equipment Source Type: alerts

Ortho-Clinical Diagnostics - VITROS Chemistry Products CHOL Slides - Class 2 Recall
VITROS Chemistry Products CHOL Slides packaged as 300 slides/pack catalog number 1669829 VITROS CHOL Slides quantitatively measure cholesterol (CHOL) 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 - November 16, 2013 Category: Medical Equipment Source Type: alerts

Alere San Diego, Inc. - Alere Cholestech LDX Calibration Verification - Class 3 Recall
Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereafter referred to as CAL VERS) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), and glucose (GLU) test procedures on the Alere Cholestech LDX System. Calibration verification is optional for CLIA waived systems, such as the Alere Cholestech LDX System, under CLIA regulations. However local or state regulations may require that calibration verification is run at regular intervals. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 30, 2013 Category: Medical Equipment Source Type: alerts

Alere San Diego, Inc. - Alere Cholestech LDX Multianalyte Control - Class 3 Recall
Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere Cholestech LDX Multianalyte Control (hereafter referred to as Controls) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), glucose (GLU), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) test procedures on the Alere Cholestech LDX System. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits....
Source: Medical Device Recalls - January 30, 2013 Category: Medical Equipment Source Type: alerts

Beckman Coulter Inc. - Synchron Systems Synchron Calibrator Multi Calibrator Diskettes - Class 3 Recall
Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. The SYNCHRON MULTI-CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate,Magnesium, Total Protein, Triglycerides, and Uric Acid. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 23, 2012 Category: Medical Equipment Source Type: alerts

Ortho-Clinical Diagnostics - VITROS - Class 2 Recall
VITROS Chemistry Products --- dHDL Slides --- Ortho Clinical Diagnostics, a Johnson&Johnson company --- [Mfg Symbol] Ortho-Clinical Diagnostics, Inc., Rochester, NY USA --- VITROS dHDL Slides are used to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS Chemistry and Integrated Systems. --- Product codes: 6801895 (60 slide count); 6802469 (18 slide count) --- indicated to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS Chemistry and Integrated Systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2012 Category: Medical Equipment Source Type: alerts

Biosite Inc Dba Innovacon Inc. - Cholestech LDX Lipid ProfileGLU test cassettes - Class 2 Recall
Cholestech LDX Lipid Profile"GLU test cassettes, Catalog Number 10-991, Lot # 245104 Cholestech LDX Lipid-Glucose tests are intended for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides, and/or glucose in whole blood, serum, and plasma. A TC/HDL (total cholesterol/HDL cholesterol) ratio and estimated values for LDL (lowdensity lipoprotein) and non-HDL cholesterol are calculated by the Cholestech LDX. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 2, 2011 Category: Medical Equipment Source Type: alerts

Diagnostic Chemicals, Ltd. - Genzyme Diagnostics Total Serum Cholesterol Kit, - Class 3 Recall
Genzyme Diagnostics Total Serum Cholesterol Kit, IVD Catalog Number: 225-26 Intended use: For the IN VITRO quantitative measurement of total serum cholesterol in serum. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 17, 2010 Category: Medical Equipment Source Type: alerts

Polymer Technology Systems, Inc. - PTS Panels CHOL+HDL Panel test strips - Class 3 Recall
PTS Panels CHOL+HDL Panel test strips for professional use with CardioChek P-A analyzer, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1795. The product is used to measure total cholesterol, and HDL cholesterol, in whole blood. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - April 3, 2010 Category: Medical Equipment Source Type: alerts

Polymer Technology Systems, Inc. - PTS Panels LDL Cholesterol test strips - Class 3 Recall
PTS Panels LDL Cholesterol test strips for professional use with CardioChek P-A test systems, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN; Catalog No. 1753. For the quantitative measurement of LDL cholesterol in whole blood. (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

Polymer Technology Systems, Inc. - PTS Panels Cholesterol test strips - Class 2 Recall
PTS Panels Cholesterol test strips for self-testing or professional use with CardioChek analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1711. Intended to provide a quantitative measurement of total cholesterol in whole blood. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - March 2, 2010 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - Dimension Vista System CHEM 1 CAL, Catalog Number KC110 - Class 2 Recall
Dimension Vista System CHEM 1 CAL, Catalog Number KC110, Lot Number 9DM001 The Dimension Vista CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN) and Uric Acid (URCA) methods on the Dimension Vista System (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - February 27, 2010 Category: Medical Equipment Source Type: alerts

Pointe Scientific, Inc. - Liquid HDL (PEG) Cholesterol Reagent Set - Class 2 Recall
Liquid HDL (PEG) Cholesterol Reagent Set. Pointe Scientific HDL Cholesterol Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # H7511-60 and Catalog # H7511-SAM. HDL Cholesterol Reagent Set, Pointe Scientific, Inc, Canton, MI; . (Clinical chemistry). For the quantitative determination of high density lipoprotein (HDL) in cholesterol in serum. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - February 26, 2010 Category: Medical Equipment Source Type: alerts

Pointe Scientific, Inc. - Liquid HDL (PEG) Cholesterol Reagent - Class 2 Recall
Liquid HDL (PEG) Cholesterol Reagent, Pointe Scientific, Inc, Canton, MI; Catalog # 7-H7511-30, 8-H7511-30, 3-H-7511-L. (Clinical chemistry). For the quantitative determination of high density lipoprotein (HDL) in cholesterol in serum. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - February 26, 2010 Category: Medical Equipment Source Type: alerts

Pointe Scientific, Inc. - AUTOHDL CHOLESTEROL REAGENT SET - Class 2 Recall
Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton, MI, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L, 7-H7545-1000, 7-H7545-320, 7-H7545-40, 7-H7545-80, H7545-1000, H7545-320, H7545-40, H7545-80, HH945-240, and HH945-480. The product is used for In vitro diagnostic for the quantitative determination of high-density lipoprotein cholesterol in human serum or plasma. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - April 28, 2009 Category: Medical Equipment Source Type: alerts

Pointe Scientific, Inc. - AUTOHDL CHOLESTEROL REAGENT SET - Class 2 Recall
Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton, MI, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L, 7-H7545-1000, 7-H7545-320, 7-H7545-40, 7-H7545-80, H7545-1000, H7545-320, H7545-40, H7545-80, HH945-240 and HH945-480. The product is used for In vitro diagnostic for the quantitative determination of high-density lipoprotein cholesterol in human serum or plasma. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - April 28, 2009 Category: Medical Equipment Source Type: alerts

Diabetes and Anti-Cholesterol Agents Top Outpatient Drug Expenditures
ROCKVILLE, Md. (MedPage Today) -- Americans spent more in 2006 on drugs for diabetes and other metabolic disorders than for any other class of medications, although psychiatric drugs cost more per prescription, said researchers here. (Source: MedPage Today Product Alert)
Source: MedPage Today Product Alert - February 6, 2009 Category: Drugs & Pharmacology Source Type: alerts

Roche Diagnostics Corp. - Roche Diagnostics HDLC3, HDL-cholesterol plus 3rd generation - Class 2 Recall
Roche Diagnostics HDLC3, HDL-Cholesterol Plus 3rd Generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 04399803190. An in-vitro diagnostic reagent system intended for use on COMAS Integra systems for the quantitative determination of HDL-cholesterol in serum and plasma. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - October 10, 2008 Category: Medical Equipment Source Type: alerts

Roche Diagnostics Corp. - Roche Diagnostics LDL_C - Class 2 Recall
Roche Diagnostics LDL_C, LDL- Cholesterol Plus 2nd generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03038866322. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of LDL-Cholesterol concentrations in serum and plasma. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - October 10, 2008 Category: Medical Equipment Source Type: alerts

Stanbio Laboratory, Inc - HDL Cholesterol Reagent - Class 2 Recall
Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-040; test kit contains 1/30mL container of Direct HDL-Cholesterol Buffer (R1) and 1/10mL container of Direct HDL-Cholesterol Enzyme (R2); in vitro diagnostic distributed by Stanbio Laboratory, Boerne, TX. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - November 21, 2006 Category: Medical Equipment Source Type: alerts

Stanbio Laboratory, Inc - HDL Cholesterol Reagent - Class 2 Recall
Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-080; test kit contains 2/30mL container of Direct HDL-Cholesterol Buffer (R1) and 2/10mL container of Direct HDL-Cholesterol Enzyme (R2); in vitro diagnostic distributed by Stanbio Laboratory, Boerne, TX. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - November 21, 2006 Category: Medical Equipment Source Type: alerts

Stanbio Laboratory, Inc - HDL Cholesterol Reagent - Class 2 Recall
Stanbio Laboratory SIRRUS Direct HDL Cholesterol LiquiColor, Catalog #S0590-540; kit contains 6 x 90 tests, HDL Buffer (R1) and HDL Enzyme (R2); in vitro diagnostic distributed by Stanbio Laboratory, Boerne, TX. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - November 21, 2006 Category: Medical Equipment Source Type: alerts

Pointe Scientific, Inc. - Class 2 Recall
Liquid AutoHDL Cholesterol Reagent Set, Manufactured for Pointe Scientific, Inc.; Catalog Nos. HH945-240, HH945-480, H7545-40, H7545-80, H7545-320 and H7545-1000. A homogeneous method for the direct determination of high density lipoprotein (HDL) cholesterol in serum or plasma. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - September 6, 2006 Category: Medical Equipment Source Type: alerts

Pointe Scientific, Inc. - Point Scientific - Class 2 Recall
Auto HDL Cholesterol reagent in bottles of 320 ml and 1000 ml, sold by Pointe Scientific; Catalog nos. 7-H7545-320 and 7-H7545-1000. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - September 5, 2006 Category: Medical Equipment Source Type: alerts

Pointe Scientific, Inc. - Class 2 Recall
AutoHDL Cholesterol R2 Reagent Set, a homogeneous method for the direct determination of high density lipoprotein (HDL) cholesterol in serum or plasma, Manufactured for Pointe Scientific, Inc.; Catalogs HH445-R2. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - September 5, 2006 Category: Medical Equipment Source Type: alerts

Pointe Scientific, Inc. - Class 2 Recall
AutoHDL Cholesterol R1 Reagent Set, a homogeneous method for the direct determination of high density lipoprotein (HDL) cholesterol in serum or plasma, Manufactured for Pointe Scientific, Inc.; Catalogs HH445-R1. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - September 5, 2006 Category: Medical Equipment Source Type: alerts

Pointe Scientific, Inc. - Class 2 Recall
AutoHDL Cholesterol Reagent Set for the quantitative determination of high density lipoprotein (HDL) cholesterol in serum or plasma, Imported and Marketed in India by Ranbaxy Fine Chemicals Ltd.; Catalogs HH7545-80. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - September 5, 2006 Category: Medical Equipment Source Type: alerts