Brand

Alere San Diego, Inc. Recalls

30 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Alere San Diego, Inc..

30Total Recalls
11Critical
891,410Units Affected
Mar 1, 2024Most Recent
All Recalls

Every Alere San Diego, Inc. Recall

Sorted by most recent. Click any recall for full details.

30 recalls
CriticalFDA
Alere San Diego, Inc.
Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
Medical Devices·559 affected·Mar 1, 2024
High RiskFDA
Alere San Diego, Inc.
The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL cholesterol, trigl...
Diabetes Devices·436,990 affected·Jun 24, 2022
High RiskFDA
Alere San Diego, Inc.
Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d - Product Usage: Th...
Diabetes Devices·186 affected·Feb 15, 2019
High RiskFDA
Alere San Diego, Inc.
Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottle of Wash Solutio...
Diagnostic Devices·2,940 affected·Nov 14, 2017
High RiskFDA
Alere San Diego, Inc.
Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5 are quality control mate...
Cardiac Devices·513 affected·Oct 12, 2016
RecallFDA
Alere San Diego, Inc.
LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The cassette is used to check the...
Medical Devices·12,951 affected·Aug 2, 2016
CriticalFDA
Alere San Diego, Inc.
Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product Usage: The INRatio/INRatio2 Test Strips perform a modified v...
Diagnostic Devices·0 affected·Jul 11, 2016
CriticalFDA
Alere San Diego, Inc.
Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product Usage: Alere INRatio 2 PT/INR Home Monitoring System: The Al...
Diagnostic Devices·0 affected·Jul 11, 2016
CriticalFDA
Alere San Diego, Inc.
Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Product Usage: The Alere INRatio¿/INRatio¿2 system uses a ...
Diagnostic Devices·0 affected·Jul 11, 2016
CriticalFDA
Alere San Diego, Inc.
Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 99007G3, 99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5...
Diagnostic Devices·0 affected·Jul 11, 2016
RecallFDA
Alere San Diego, Inc.
Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test Device a simple test that uti...
Medical Devices·0 affected·Jun 22, 2016
RecallFDA
Alere San Diego, Inc.
Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine erythrocytes to qual...
Medical Devices·0 affected·Jun 22, 2016
RecallFDA
Alere San Diego, Inc.
Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that utilizes an extract of bovine erythrocytes to qualitatively a...
Medical Devices·0 affected·Jun 22, 2016
RecallFDA
Alere San Diego, Inc.
Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple test that utilizes an extract of bovine erythrocytes to qualit...
Medical Devices·0 affected·Jun 22, 2016
RecallFDA
Alere San Diego, Inc.
Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor the performance of total cholesterol (TC), h...
Diabetes Devices·190 affected·Aug 27, 2015
CriticalFDA
Alere San Diego, Inc.
Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio PT/INR Test Strips, Box of 12 - 010...
Diagnostic Devices·77,342 affected·Dec 5, 2014
CriticalFDA
Alere San Diego, Inc.
INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432 Alere INRatio 2 PT/INR Home Monitoring System...
Diagnostic Devices·231,967 affected·Dec 5, 2014
High RiskFDA
Alere San Diego, Inc.
Alere Triage¿ D-Dimer Test PN 98100, Lot W53884B. The Alere Triage¿ D-Dimer Test is a fluorescence immunoassay to be used with the Aler...
Diagnostic Devices·373 affected·May 2, 2014
High RiskFDA
Alere San Diego, Inc.
Product Brand Name(s): Alere Triage¿ TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56035B. 25 individually pouched devi...
Diagnostic Devices·305 affected·Feb 5, 2014
RecallFDA
Alere San Diego, Inc.
Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory...
Medical Devices·38 affected·Sep 23, 2013
High RiskFDA
Alere San Diego, Inc.
Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (AL...
Medical Devices·38,571 affected·Mar 6, 2013
RecallFDA
Alere San Diego, Inc.
IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chr...
Diagnostic Devices·78 affected·Feb 26, 2013
RecallFDA
Alere San Diego, Inc.
Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a rapid chromato...
Diagnostic Devices·2,167 affected·Jan 21, 2013
RecallFDA
Alere San Diego, Inc.
Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereaf...
Diabetes Devices·614 affected·Oct 22, 2012
CriticalFDA
Alere San Diego, Inc.
Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of creatine kinase MB, myoglobin, troponin I and ...
Medical Devices·16,962 affected·May 22, 2012
CriticalFDA
Alere San Diego, Inc.
Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic p...
Medical Devices·5,013 affected·May 22, 2012
CriticalFDA
Alere San Diego, Inc.
Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coa...
Medical Devices·1,972 affected·May 22, 2012
CriticalFDA
Alere San Diego, Inc.
Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin and troponin I...
Cardiac Devices·6,044 affected·May 22, 2012
High RiskFDA
Alere San Diego, Inc.
Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used w...
Diagnostic Devices·9,997 affected·May 14, 2012
High RiskFDA
Alere San Diego, Inc.
Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay intended to be ...
Diagnostic Devices·45,638 affected·May 28, 2009