Alere San Diego, Inc. recalls
Every recall we track for Alere San Diego, Inc. — 8 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
8 recalls since 2017.
All FDA recall records for Alere San Diego, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 1 | 0 | 1 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 1 | 0 | 1 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 1 | 0 | 1 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 1 | 0 | 0 | 1 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 1 | 3 | 4 |
What to do if you have a recalled Alere San Diego, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Alere San Diego, Inc. recalls
5 shown- Lower riskMedical device
Alere San Diego, Inc. recalls Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON
Alere recalls hCG pregnancy tests that may detect low hCG levels, causing false positives. Affected products include Sure-Vue and ICON tests with specific model numbers and dates.
AlereAug 20, 2026 - Use cautionMedical device
Alere San Diego, Inc. recalls Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
Abbott recalls Cholestech LDX Battery Kit (Model 3LP656194-PCM-LD) due to potential swelling causing minor burns, cuts, or electrical shocks. Affected units may need replacement.
AbbottMar 1, 2024 - Lower riskMedical device
Alere San Diego, Inc. recalls The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL
Alere recalls Cholestech LDX cholesterol test cassettes that may give inaccurate results when bilirubin levels exceed certain thresholds. Update package insert with new interference information to avoid false low HDL and triglyceride readings.
AlereJun 24, 2022 - Lower riskMedical device
Alere San Diego, Inc. recalls Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d -
Alere recalls Cholestech LDX Analyzer model 14-874 with specific power supplies (1837d, 1843d) due to reversed polarity making the device inoperable. Affected units include listed lot/serial numbers.
AlereFeb 15, 2019 - Lower riskMedical device
Alere San Diego, Inc. recalls Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1
Alere recalls Triage Drugs of Abuse Plus TCA 25 Test Kits with model numbers 92000, 92590, 92591 due to unexpected false positive THC results. Affected kits may show incorrect drug test results.
AlereNov 14, 2017
Alere San Diego, Inc. recall questions
How many recalls has Alere San Diego, Inc. had?
8 recalls from Alere San Diego, Inc. are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Alere San Diego, Inc. recall?
Alere San Diego, Inc. recalls Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON, dated Aug 20, 2026. Every Alere San Diego, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Alere San Diego, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Alere San Diego, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.