Alere San Diego recalls

Alere San Diego has 54 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 7 Oct 2026. 6 are still ongoing. 4 were reported in the last 12 months. The most frequent reason is packaging defects.

Total recalls54since 2012

Last 12 months4reported

Class I1833% of total

Ongoing6latest 7 Oct 2026

Recalls per month, last 24 months

click a bar for that month

0Dec '24 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0 0Dec 0 0 0Mar 0 0 0Jun 0 0 0Sep 4 0

Severity split

Class I 18 33%Class II 19 35%Class III 17 31%

Why alere san diego is recalled

Product types

By year

202647%
202412%
202212%
201912%
201824%
20161833%
201547%
2014611%
2013917%
2012815%

Ongoing alere san diego recalls

6 active

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	Fisher Scientific Sure-Vue Urine hCG Strip recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
7 Oct 2026Device	CLASS II	McKesson Consult hCG Urine Cassette recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
7 Oct 2026Device	CLASS II	Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
7 Oct 2026Device	CLASS II	Fisher Scientific Sure-Vue Serum/Urine hCG recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
8 May 2024Device	CLASS II	Abbott Cholestech LDX Battery Kit recalled by Alere San Diego	Alere San Diego	E. coli	Nationwide
17 Aug 2022Device	CLASS II	The Cholestech LDX¿ System combines enzymatic methodology recalled	Alere San Diego	Packaging Defects	31 states

All alere san diego recalls, newest first

54 total

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	Fisher Scientific Sure-Vue Urine hCG Strip recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
7 Oct 2026Device	CLASS II	McKesson Consult hCG Urine Cassette recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
7 Oct 2026Device	CLASS II	Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
7 Oct 2026Device	CLASS II	Fisher Scientific Sure-Vue Serum/Urine hCG recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
8 May 2024Device	CLASS II	Abbott Cholestech LDX Battery Kit recalled by Alere San Diego	Alere San Diego	E. coli	Nationwide
17 Aug 2022Device	CLASS II	The Cholestech LDX¿ System combines enzymatic methodology recalled	Alere San Diego	Packaging Defects	31 states
11 Sep 2019Device	CLASS II	Alere Cholestech LDX Analyzer recalled by Alere San Diego	Alere San Diego	E. coli	Nationwide
20 Jun 2018Device	CLASS III	lmmunalysis Eddp Urine Control Set 1 The Eddp Urine recalled	Alere San Diego	Potency & Assay	14 states
7 Feb 2018Device	CLASS II	Triage Drugs of Abuse Plus TCA 25 Test Kit recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
23 Nov 2016Device	CLASS II	The Triage Total Controls 5 are quality control materials recalled	Alere San Diego	Potency & Assay	Nationwide
21 Sep 2016Device	CLASS III	LDX Optical Check Cassettes (OCC) recalled by Alere San Diego	Alere San Diego	Device Malfunction	Nationwide
31 Aug 2016Device	CLASS I	Alere INRatio PT/INR System Professional recalled by Alere San Diego	Alere San Diego	Other	Nationwide
31 Aug 2016Device	CLASS I	Alere INRatio2 PT/INR Home Monitoring System recalled by Alere San Diego	Alere San Diego	Other	Nationwide
31 Aug 2016Device	CLASS I	INRatio Prothrombin Time (PT) Monitoring System recalled	Alere San Diego	Other	Nationwide
31 Aug 2016Device	CLASS I	Alere INRatio Replacement Monitor recalled by Alere San Diego	Alere San Diego	Other	Nationwide
31 Aug 2016Device	CLASS I	Alere INRatio2 PT/INR Professional Testing System recalled	Alere San Diego	Other	Nationwide
31 Aug 2016Device	CLASS I	Alere INRatio/ INRatio2 PT/INR Test Strips recalled by Alere San Diego	Alere San Diego	Other	Nationwide
31 Aug 2016Device	CLASS I	Alere INRatio2 PT/INR Professional Monitoring System recalled	Alere San Diego	Other	Nationwide
31 Aug 2016Device	CLASS I	Alere INRatio2 Replacement Monitor (Home) recalled by Alere San Diego	Alere San Diego	Other	Nationwide
31 Aug 2016Device	CLASS I	Alere INRatio PT/INR Test Strips recalled by Alere San Diego	Alere San Diego	Temperature Abuse	Nationwide
3 Aug 2016Device	CLASS III	Clearview MONO (Whole Blood, Serum, Plasma) recalled by Alere San Diego	Alere San Diego	Packaging Defects	CA
3 Aug 2016Device	CLASS III	Stanbio Rely Mono Rapid Test recalled by Alere San Diego	Alere San Diego	Packaging Defects	CA
3 Aug 2016Device	CLASS III	Proadvantage Mono Rapid Test Cassette recalled by Alere San Diego	Alere San Diego	Packaging Defects	CA
3 Aug 2016Device	CLASS III	Signify Mono (Whole Blood, Serum, Plasma) recalled by Alere San Diego	Alere San Diego	Packaging Defects	CA
3 Aug 2016Device	CLASS III	Cardinal Health Mono Rapid Test recalled by Alere San Diego	Alere San Diego	Packaging Defects	CA
3 Aug 2016Device	CLASS III	Henry Schein One Step + Mono Rapid Test Device recalled	Alere San Diego	Packaging Defects	CA
3 Aug 2016Device	CLASS III	Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma) recalled	Alere San Diego	Packaging Defects	CA
21 Oct 2015Device	CLASS III	Alere Cholestech LDX Multianalyte Controls, PN recalled	Alere San Diego	E. coli	Nationwide
14 Jan 2015Device	CLASS I	INRatio Monitors - 0100004 Alere INRatio PT/INR System recalled	Alere San Diego	Packaging Defects	Nationwide
14 Jan 2015Device	CLASS I	INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR recalled	Alere San Diego	Packaging Defects	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.