Alere San Diego, Inc.
Complete recall history across all FDA and CPSC categories — 49 total recalls
Alere San Diego, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (49)
FDA medical device enforcement actions by Alere San Diego, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Mar 1, 2024 | Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170 | There is a potential that the Cholestech LDX battery (an external battery pac... | Class II |
| Jun 24, 2022 | The Cholestech LDX¿ System combines enzymatic methodology and solidphase tec... | Cholesterol test cassettes package insert is to be updated with new bilirubin... | Class II |
| Feb 15, 2019 | Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with ... | The polarity of the output of power supply was reversed. Due to polarity of... | Class II |
| Nov 14, 2017 | Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591... | The recalled lots have demonstrated unexpected false positive THC results. | Class II |
| Oct 12, 2016 | Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the p... | Encoded with incorrect ranges that are not consistent with the ranges printed... | Class II |
| Aug 2, 2016 | LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassett... | Incorrect expiration date on the magnetic strip that does not match the label... | Class III |
| Jul 11, 2016 | Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product U... | Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRat... | Class I |
| Jul 11, 2016 | Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432, 0200433 ... | Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRat... | Class I |
| Jul 11, 2016 | INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Pr... | Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRat... | Class I |
| Jul 11, 2016 | Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRa... | Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRat... | Class I |
| Jul 11, 2016 | Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 P... | Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRat... | Class I |
| Jul 11, 2016 | Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 9... | Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRat... | Class I |
| Jul 11, 2016 | Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A ... | Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRat... | Class I |
| Jul 11, 2016 | Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product U... | Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRat... | Class I |
| Jul 11, 2016 | Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product U... | Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRat... | Class I |
| Jun 22, 2016 | Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401 a simple tes... | The Positive Control information referencing human plasma as the antibody mat... | Class III |
| Jun 22, 2016 | Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple ... | The Positive Control information referencing human plasma as the antibody mat... | Class III |
| Jun 22, 2016 | Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test th... | The Positive Control information referencing human plasma as the antibody mat... | Class III |
| Jun 22, 2016 | Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple te... | The Positive Control information referencing human plasma as the antibody mat... | Class III |
| Jun 22, 2016 | Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that u... | The Positive Control information referencing human plasma as the antibody mat... | Class III |
| Jun 22, 2016 | Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple ... | The Positive Control information referencing human plasma as the antibody mat... | Class III |
| Jun 22, 2016 | Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92... | The Positive Control information referencing human plasma as the antibody mat... | Class III |
| Aug 27, 2015 | Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables u... | Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control be... | Class III |
| Dec 5, 2014 | INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 01000... | In certain cases, an INRatio PT/INR Monitor system may provide an INR result ... | Class I |
| Dec 5, 2014 | INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing Sys... | In certain cases, an INRatio PT/INR Monitor system may provide an INR result ... | Class I |
| Dec 5, 2014 | Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional ... | In certain cases, an INRatio PT/INR Monitor system may provide an INR result ... | Class I |
| May 30, 2014 | Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoa... | Alere San Diego is recalling Alere Triage BNP Calibrators for the Beckman Cou... | Class III |
| May 2, 2014 | Alere Triage¿ D-Dimer Test PN 98100, Lot W53884B. The Alere Triage¿ D-Dimer... | Alere initiated this recall because a limited number of Alere Triage¿ D-Dimer... | Class II |
| Apr 16, 2014 | Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Al... | Test Strips may report an inaccurately low INR result. Several patients had ... | Class I |
| Mar 20, 2014 | Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Sy... | These lots may not recover within range when tested using certain commerciall... | Class II |
| Feb 5, 2014 | Product Brand Name(s): Alere Triage¿ TOX+MTD Drug Screen, Catalog Number 9440... | Alere San Diego, Inc. is initiating a recall of the Alere Triage¿ TOX Drug Sc... | Class II |
| Oct 23, 2013 | Product Brand Name(s): Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette,... | Alere initiated a recall of Cholestech LDX Lipid Profile-GLU test cassettes, ... | Class III |
| Sep 23, 2013 | Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Cont... | Alere San Diego, Inc. initiated a voluntary recall of Alere Triage TOX Drug S... | Class III |
| Jun 3, 2013 | Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert O... | Alere initiated this recall of certain lots of the Oral Fluid Drug Screen Dev... | Class II |
| Apr 16, 2013 | Alere" hCG Combo Cassette (20/10 mIU/mL) Kit. Product Usage: The AlereT... | The firm initiated recall of Alere" hCG Combo Cassette (20/10 mIU/mL) kit PN ... | Class II |
| Mar 6, 2013 | The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) Test Ca... | The Alere Cholestech LDX¿ hsCRP cassette (PN 12-807) may have increased impr... | Class II |
| Mar 6, 2013 | Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitr... | The recall was initiated because Alere San Diego has an update for the Alere ... | Class II |
| Feb 26, 2013 | IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog ... | Alere San Diego is recalling the Clearview Mononucleosis Cassette because the... | Class III |
| Jan 21, 2013 | Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 45821... | Alere San Diego Inc. is recalling the Cardinal Health hCG Cassette Rapid Test... | Class III |
| Oct 22, 2012 | Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 ... | Out of range (increased) HDL Cholesterol results. | Class III |
| Oct 22, 2012 | Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88... | Out of range (increased) HDL Cholesterol results. | Class III |
| Jul 12, 2012 | Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Dru... | Alere San Diego is recalling Alere Triage TOX Drug Screen because there is a ... | Class II |
| May 22, 2012 | Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis... | Certain lots of the affected products may have significantly decreased precis... | Class I |
| May 22, 2012 | Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determinat... | Certain lots of the affected products may have significantly decreased precis... | Class I |
| May 22, 2012 | Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of... | Certain lots of the affected products may have significantly decreased precis... | Class I |
| May 22, 2012 | Alere Triage Profiler SOB Panel PN 97300 Used for the determination of cre... | Certain lots of the affected products may have significantly decreased precis... | Class I |
| May 22, 2012 | Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative det... | Certain lots of the affected products may have significantly decreased precis... | Class I |
| May 14, 2012 | Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triag... | A recall was initiated because Alere San Diego has confirmed that the Triage ... | Class II |
| May 28, 2009 | Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage T... | Biosite is recalling the Triage TOX Drug Screen kits where the box containing... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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