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Beckman Coulter Inc. - Synchron Systems Cholesterol Reagent - Class 2 Recall
Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative determination of cholesterol concentration in human serum or plasma. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 13, 2017 Category: Medical Devices Source Type: alerts

Beckman Coulter Inc. - Synchron Systems HDL Cholesterol Reagent - Class 2 Recall
HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 13, 2017 Category: Medical Devices Source Type: alerts

Sterling Diagnostics, Inc. - Sterling Diagnostics, Inc. Enzymatic Cholesterol (Trinder/CODCEH) - Class 3 Recall
Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 30, 2016 Category: Medical Equipment Source Type: alerts

Sterling Diagnostics, Inc. - Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) - Class 3 Recall
Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 30, 2016 Category: Medical Equipment Source Type: alerts

CHOLESTERINUM (Cholesterol) Pellet [Washington Homeopathic Products]
Updated Date: Dec 6, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 6, 2016 Category: Drugs & Pharmacology Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - Dimension Vista Chemistry 1 Calibrator - Class 2 Recall
Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA/CRE2), 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 - November 23, 2016 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - Advia Chemistry Systems Calibrator - Class 2 Recall
Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the following methods: Albumin (ALB, ALB_c), Direct Bilirubin (DBIL_2), Total Bilirubin (TBIL_2), Calcium (CA, CA_c, CA_2, CA_2c), Cholesterol (CHOL), Creatinine (CREA, CREA_2, CRE_2c, ECRE_2), Glucose Hexakinase (GLUH), Glucose Oxidase (GLUO), Iron (IRON_2), Lithium (LITH), Magnesium (MG, MG_c), Phosphorus - inorganic (IP, IP_c), Total Protein (TP, TP_c), Triglycerides (TRIG), Urea Nitrogen (UN, UN_c), Uric Acid (UA, UA_c) (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 17, 2016 Category: Medical Equipment Source Type: alerts

Michael ’ s ® Naturopathic Programs Issues Allergy Alert on Undeclared Milk and Soy in The Dietary Supplement Cholesterol Metabolism Factors ™
Michael ’ s ® Naturopathic Programs of San Antonio Texas is recalling certain lots of the dietary supplement Cholesterol Metabolism Factors ™ , because it may contain undeclared milk (in the form of calcium caseinate) and soy. People who have an allergy or severe sensitivity to milk and soy run the risk of serious or life-threatening allergic reaction if they consume these products. (Source: FDA Food Alergies)
Source: FDA Food Alergies - June 24, 2016 Category: Food Science Source Type: alerts

Michael ’s® Naturopathic Programs Issues Allergy Alert on Undeclared Milk and Soy in The Dietary Supplement Cholesterol Metabolism Factors™
Michael ’s® Naturopathic Programs of San Antonio Texas is recalling certain lots of the dietary supplement Cholesterol Metabolism Factors™, because it may contain undeclared milk (in the form of calcium caseinate) and soy. People who have an allergy or severe sensitivity to milk and soy run the risk o f serious or life-threatening allergic reaction if they consume these products. (Source: FDA Food Alergies)
Source: FDA Food Alergies - June 24, 2016 Category: Food Science Source Type: alerts

Beckman Coulter Inc. - Cholesterol OSR6x16 - Class 2 Recall
Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is intended as a System reagent for the quantitative determination of Cholesterol concentrations in human serum on Beckman Coulter AU analyzers. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 9, 2016 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - Direct HDL Cholesterol (AHDL) - Class 2 Recall
Dimension Vista Assays: Direct HDL Cholesterol (AHDL) (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 12, 2016 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - Direct HDL Cholesterol (AHDL) - Class 2 Recall
Dimension Assays: Direct HDL Cholesterol (AHDL) (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 12, 2016 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - Direct HDL Cholesterol (DHDL) - Class 2 Recall
Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL) (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 12, 2016 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - Cholesterol_2 & Concentrated Cholesterol_c - Class 2 Recall
Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 12, 2016 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - LDL Cholesterol, Direct (DLDL) - Class 2 Recall
Advia Chemistry Assay: LDL Cholesterol, Direct (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 12, 2016 Category: Medical Equipment Source Type: alerts

Horiba Instruments Inc - ABX PENTRA Cholesterol CPref. A11A01634 - Class 2 Recall
The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for quantitative determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinder s reaction). The assay is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 3, 2016 Category: Medical Equipment Source Type: alerts

ELITech Clinical Systems SAS - Envoy 500 - Class 2 Recall
Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450 ENVOY 500 URIC ACID REAGENT KIT 55435 ENVOY 500 TRIGLYCERIDES REAGENT KIT, 55297 ENVOY 500 CHOLESTEROL REAGENT KIT, 55335 ENVOY 500 CREATININE REAGENT KIT 55301 ENVOY 500 HDL CHOLESTEROL REAGENT 55310 ENVOY 500 LDL CHOLESTEROL REAGENT KIT (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 5, 2015 Category: Medical Equipment Source Type: alerts

ELITech Clinical Systems SAS - Eon 100 system - Class 2 Recall
Eon 100 system included the following product reference numbers and names: Reference no. 77345- Glucose (GPSL) Reference no. 77450- Uric acid (AUVD) Reference no. 77435- Triglycerides (TGML) Reference no. 77295- Cholesterol (CHVD) Reference no. 77301- Cholesterol HDL (HDLL) Reference no. 77310- Cholesterol, LDL (LDLL) (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 5, 2015 Category: Medical Equipment Source Type: alerts

ELITech Clinical Systems SAS - Selectra ProS and ProM systems - Class 2 Recall
ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method. The following product reference numbers and names: GPSL-025O: Glucose PAP SL AUML-0250: URIC ACID MONO SL CHSL-0250: CHOLESTEROL SL, TGML-0250: TRIGLYCERIDES SL, CRSL-0250: CREATININE PAP SL HDLL-0230: CHOLESTEROL HDL SL 2G LDLL-0230: CHOLESTEROL LDL SL 2G (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 5, 2015 Category: Medical Equipment Source Type: alerts

ELITech Clinical Systems SAS - Eon 300 system - Class 2 Recall
Eon 300 system includes the following product reference numbers and names: Reference no. 79345 Glucose (GPSL) Reference no. 79450 Uric acid (AUVD) Reference no. 79435 Triglycerides (TGML) Reference no. 79295 Cholesterol (CHVD) Reference no. 79301 Cholesterol HDL (HDLL) Reference no. 79310 Cholesterol, LDL (LDLL) (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 5, 2015 Category: Medical Equipment Source Type: alerts

Alere San Diego, Inc. - Alere Cholestech LDX Multianalyte Controls - Class 3 Recall
Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG) and glucose (GLU) test procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 16, 2015 Category: Medical Equipment Source Type: alerts

Pointe Scientific, Inc. - Pointe Scientific, Med Test - Class 3 Recall
Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2 Kits: HDPE plastic bottle, PP plastic caps. Bulk: PE plastic cube containers, PP plastic caps. Quantitative determination of high density lipoprotein cholesterol in human serum or plasma. In vitro diagnostic use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 15, 2015 Category: Medical Equipment Source Type: alerts

Roche Diagnostics Operations, Inc. - Boehringer Mannheim Direct LDLCholesterol - Class 2 Recall
LDL-Cholesterol plus gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 28, 2015 Category: Medical Equipment Source Type: alerts

Roche Diagnostics Operations, Inc. - HDLCholesterol, no pretreatment - Class 2 Recall
HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 28, 2015 Category: Medical Equipment Source Type: alerts

Roche Diagnostics Operations, Inc. - HDLCholesterol, - Class 2 Recall
HDL-Cholesterol plus gen.3. Intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of HDL-cholesterol concentration in serum and plasma. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 28, 2015 Category: Medical Equipment Source Type: alerts

Roche Diagnostics Operations, Inc. - Boehringer Mannheim Cholesterol Assay - Class 2 Recall
Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitachi systems for The quantitative determination of total cholesterol in serum and plasma. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 28, 2015 Category: Medical Equipment Source Type: alerts

Roche Diagnostics Operations, Inc. - LDLCholesterol plus 2nd Generation - Class 2 Recall
LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 28, 2015 Category: Medical Equipment Source Type: alerts

Roche Diagnostics Operations, Inc. - Total Cholesterol Assay - Class 2 Recall
Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of total cholesterol in serum and plasma. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 28, 2015 Category: Medical Equipment Source Type: alerts

BHI BODYPURE (.Alpha.-Lipoic Acid, Avena Sativa Flowering Top, Berberis Vulgaris Root Bark, Caffeine, Cholesterol, Juglans Regia Flowering Top, Strychnos Nux-Vomica Seed, Kerosene, Frangula Purshiana Bark, Ricinus Communis Seed, Solidago Virgaurea Flowering Top, Urtica Urens, Viola Tricolor, And Alcohol, X-Ray Exposed (1000 Rad)) Tablet [MediNatura Inc]
Updated Date: Mar 24, 2015 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - March 24, 2015 Category: Drugs & Pharmacology Source Type: alerts

Beckman Coulter Inc. - Beckman Coulter, Cholesterol Assay - Class 2 Recall
Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 29, 2015 Category: Medical Equipment Source Type: alerts

CHOLESTEROL (Cholesterinum) Liquid [Deseret Biologicals, Inc.]
Updated Date: Jan 20, 2015 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - January 20, 2015 Category: Drugs & Pharmacology Source Type: alerts

DR. KARRS ACNE-STATIN (Salicylic Acid) Cream [COLONIAL DAMES CO LTD]
Updated Date: Dec 22, 2014 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - December 22, 2014 Category: Drugs & Pharmacology Source Type: alerts

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

ARTERY/CHOLESTEROL/BP (Aurum Metallicum, Aurum Muriaticum Natronatum, Baryta Carbonica, Baryta Muriatica, Calcarea Fluorica, Ceanothus Americanus, Cholesterinum, Glonoinum, Plumbum Iodatum, Strophanthus Hispidus) Liquid [King Bio Inc.]
Updated Date: Apr 17, 2014 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - April 17, 2014 Category: Drugs & Pharmacology Source Type: alerts

HEARTERY (American Ginseng, Arnica Montana, Gold, Barium Carbonate, Atropa Belladonna, Calcium Fluoride, Cholesterol, Herring Sperm Dna, Ginkgo, Saccharomyces Cerevisia Rna, Visbum Album Fruiting Top, And Ginger) Spray [Sunway Biotech LLC]
Updated Date: Dec 18, 2013 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - December 18, 2013 Category: Drugs & Pharmacology 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 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

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

MALE PLUS (Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Aldosterone, Androsterone, Adenosine Cyclic 3,5-Phosphate, Cholesterol, Prasterone, Somatropin, Bos Taurus Hypothalamus, Sus Scrofa Hypothalamus, Melatonin, Bos Taurus Pancreas, Sus Scrofa Pancreas, Bos Taurus Pineal Gland, Sus Scrofa Pineal Gland, Bos Taurus Pituitary Gland, Sus Scrofa Pituitary Gland, Bos Taurus Prostate Gland, Sus Scrofa Prostate, Bos Taurus Testicle, Sus Scrofa Testicle, Testosterone, Sus Scrofa Thalamus) Spray [VIATREXX BIO INCORPORATED]
Updated Date: Apr 29, 2013 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - April 29, 2013 Category: Drugs & Pharmacology 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