PlainRecalls

Alere San Diego, Inc.

32 recalls on record · Latest: May 8, 2024

Alere San Diego, Inc. Recall Insight

Alere San Diego, Inc. appears on 32 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.038% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated May 8, 2024, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 32 entries, severity tagging shows 12 critical, 10 moderate, and 10 lower-severity recalls. Affected-unit counts are disclosed on 28 of 32 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (32). The date window on this page runs from Jul 18, 2012 to May 8, 2024.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate May 8, 2024

Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170

FDA Devices Moderate Aug 17, 2022

The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL cholesterol, triglycerides and…

FDA Devices Moderate Sep 11, 2019

Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d - Product Usage: The Alere Chol…

FDA Devices Moderate Feb 7, 2018

Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottle of Wash Solution, 1 Pipette…

FDA Devices Moderate Nov 23, 2016

Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5 are quality control materials that a…

FDA Devices Low Sep 21, 2016

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 optics syst…

FDA Devices Critical Aug 31, 2016

Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product Usage: The INRatio/INRatio2 Test Strips perform a modified version of th…

FDA Devices Critical Aug 31, 2016

Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product Usage: Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio …

FDA Devices Critical Aug 31, 2016

Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Product Usage: The Alere INRatio¿/INRatio¿2 system uses a modified ver…

FDA Devices Critical Aug 31, 2016

Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 99007G3, 99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5, 99008G7 …

FDA Devices Low Aug 3, 2016

Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test Device a simple test that utilizes an ext…

FDA Devices Low Aug 3, 2016

Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine erythrocytes to qualitatively an…

FDA Devices Low Aug 3, 2016

Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selective…

FDA Devices Low Aug 3, 2016

Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and …

FDA Devices Low Oct 21, 2015

Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor the performance of total cholesterol (TC), high density …

FDA Devices Critical Jan 14, 2015

Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio PT/INR Test Strips, Box of 12 - 0100139 Alere I…

FDA Devices Critical Jan 14, 2015

INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432 Alere INRatio 2 PT/INR Home Monitoring System - 0200433 …

FDA Devices Critical Jan 14, 2015

INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio Prothrombin Time (PT) Monitoring System - 0100137 Alere INRa…

FDA Devices Moderate Jun 18, 2014

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 Triage¿ Me…

FDA Devices Moderate Mar 26, 2014

Product Brand Name(s): Alere Triage¿ TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56035B. 25 individually pouched devices in a lab…

FDA Devices Low Oct 30, 2013

Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice su…

FDA Devices Low May 29, 2013

Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a rapid chromatographic immu…

FDA Devices Low Apr 24, 2013

IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chromatographic…

FDA Devices Moderate Apr 24, 2013

Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspar…

FDA Devices Low Feb 6, 2013

Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereafter referred…

FDA Devices Moderate Oct 17, 2012

Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with th…

FDA Devices Moderate Jul 25, 2012

Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used with the Aler…

FDA Devices Critical Jul 18, 2012

Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of creatine kinase MB, myoglobin, troponin I and B-type natri…

FDA Devices Critical Jul 18, 2012

Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and …

FDA Devices Critical Jul 18, 2012

Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or …

FDA Devices Critical Jul 18, 2012

Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin and troponin I in EDTA ant…

FDA Devices Critical Jul 18, 2012

Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred t…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Alere San Diego, Inc. with FORD →

Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds