Alere San Diego recalls
Alere San Diego appears in 50 official U.S. recall notices indexed by RecallRadar, most recently on 2024-05-08.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
FDA Device · Class II · 2024-05-08 · Alere San Diego - The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL cholesterol, triglyce…
FDA Device · Class II · 2022-08-17 · Alere San Diego - Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d - Product Usage: The…
FDA Device · Class II · 2019-09-11 · Alere San Diego - lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonol…
FDA Device · Class III · 2018-06-20 · Alere San Diego - Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591
FDA Device · Class II · 2018-02-07 · Alere San Diego - Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5 are quality control materials…
FDA Device · Class II · 2016-11-23 · Alere San Diego - LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert
FDA Device · Class III · 2016-09-21 · Alere San Diego - Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product Usage: Alere INRatio ¿ 2 PT/INR Monitoring System (Professional Use…
FDA Device · Class I · 2016-08-31 · Alere San Diego - Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432, 0200433 Product Usage: Alere INRatio 2 PT/INR Home Monitoring System: T…
FDA Device · Class I · 2016-08-31 · Alere San Diego - Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product Usage: Alere INRatio 2 PT/INR Home Monitoring System: The Alere INR…
FDA Device · Class I · 2016-08-31 · Alere San Diego - Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product Usage: The INRatio/INRatio2 Test Strips perform a modified version…
FDA Device · Class I · 2016-08-31 · Alere San Diego - Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 Product Usage: The INRatio 2 PT Monitoring system is used for the q…
FDA Device · Class I · 2016-08-31 · Alere San Diego - Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement…
FDA Device · Class I · 2016-08-31 · Alere San Diego - INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Product Usage: The INRatio Prothrombin Time Monitoring System uses a…
FDA Device · Class I · 2016-08-31 · Alere San Diego - Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 99007G3, 99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5, 9…
FDA Device · Class I · 2016-08-31 · Alere San Diego - Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Product Usage: The Alere INRatio¿/INRatio¿2 system uses a modifie…
FDA Device · Class I · 2016-08-31 · Alere San Diego - Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that utilizes an extract of bovine erythrocytes to qualitatively and s…
FDA Device · Class III · 2016-08-03 · Alere San Diego - Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes an extract of bovine erythrocytes to qualitatively a…
FDA Device · Class III · 2016-08-03 · Alere San Diego - Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404
FDA Device · Class III · 2016-08-03 · Alere San Diego - Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple test that utilizes an extract of bovine erythrocytes to qualitativ…
FDA Device · Class III · 2016-08-03 · Alere San Diego - Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine erythrocytes to qualit…
FDA Device · Class III · 2016-08-03 · Alere San Diego - Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple test that utilizes an extract of bovine erythrocytes to qualitat…
FDA Device · Class III · 2016-08-03 · Alere San Diego - Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401 a simple test that utilizes an extract of bovine erythrocytes to qualitative…
FDA Device · Class III · 2016-08-03 · Alere San Diego - Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773
FDA Device · Class III · 2015-10-21 · Alere San Diego - INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432 Alere INRatio 2 PT/INR Home Monitoring System - 0…
FDA Device · Class I · 2015-01-14 · Alere San Diego - INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio Prothrombin Time (PT) Monitoring System - 0100137 Ale…
FDA Device · Class I · 2015-01-14 · Alere San Diego - Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio PT/INR Test Strips, Box of 12 - 0100139…
FDA Device · Class I · 2015-01-14 · Alere San Diego - Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202 The Alere Triage BNP test is int…
FDA Device · Class III · 2014-07-02 · Alere San Diego - Alere Triage¿ D-Dimer Test PN 98100, Lot W53884B. The Alere Triage¿ D-Dimer Test is a fluorescence immunoassay to be used with the Alere Tr…
FDA Device · Class II · 2014-06-18 · Alere San Diego - Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere INRatio2 PT/INR Monitoring System (Professional Use), cons…
FDA Device · Class I · 2014-05-14 · Alere San Diego - Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Model Number 98200, Lot Numbers: 329599, 331265
FDA Device · Class II · 2014-05-14 · Alere San Diego - Product Brand Name(s): Alere Triage¿ TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56035B. 25 individually pouched devices i…
FDA Device · Class II · 2014-03-26 · Alere San Diego - Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Devic…
FDA Device · Class II · 2014-01-15 · Alere San Diego - Product Brand Name(s): Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette, Model 10-991
FDA Device · Class III · 2013-12-04 · Alere San Diego - Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice…
FDA Device · Class III · 2013-10-30 · Alere San Diego - Alere" hCG Combo Cassette (20/10 mIU/mL) Kit
FDA Device · Class II · 2013-06-05 · Alere San Diego - Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a rapid chromatograph…
FDA Device · Class III · 2013-05-29 · Alere San Diego - The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807
FDA Device · Class II · 2013-05-01 · Alere San Diego - IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma)
FDA Device · Class III · 2013-04-24 · Alere San Diego - Alere Cholestech LDX ALT AST Test Cassette, Model #12-788
FDA Device · Class II · 2013-04-24 · Alere San Diego - Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere Cholestech LDX Multianalyte Control (hereafter referred…
FDA Device · Class III · 2013-02-06 · Alere San Diego - Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereafter r…
FDA Device · Class III · 2013-02-06 · Alere San Diego - Triage TOX Drug Screen Panel, Model# 94400
FDA Device · Class II · 2012-10-17 · Alere San Diego - Alere Triage TOX Drug Screen 9 Panel, P/N: 94402
FDA Device · Class II · 2012-10-03 · Alere San Diego - Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used with th…
FDA Device · Class II · 2012-07-25 · Alere San Diego - Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of creatine kinase MB, myoglobin, troponin I and B-typ…
FDA Device · Class I · 2012-07-18 · Alere San Diego - Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also ref…
FDA Device · Class I · 2012-07-18 · Alere San Diego - Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulat…
FDA Device · Class I · 2012-07-18 · Alere San Diego - Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptid…
FDA Device · Class I · 2012-07-18 · Alere San Diego - Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin and troponin I in E…
FDA Device · Class I · 2012-07-18 · Alere San Diego