Alere San Diego, Inc.
FDA Regulatory Profile
Alere San Diego, Inc. has 53 FDA recalls (18 Class I), 9 inspections, 2 510(k) clearances and 1 compliance action on record.
- Latest recall
- Z-3274-2026 · Class II · Aug 20, 2026
- Latest inspection
- Dec 10, 2025 · NAI
- Latest 510(k)
- Sep 20, 2023
Newer recall under related name Abbott: Sep 10, 2026, Z-0191-2027.
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 53 (18 Class I) | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 2 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 9 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Related names
| Name | Recalls | 510(k) | Inspections | Compliance | Most recent recall |
|---|
Abbott
Same company group | 22 | 13 | 17 | 0 | Sep 10, 2026 (Z-0191-2027) |
Thoratec
Same company group | 24 | 1 | 10 | 1 | May 13, 2026 (Z-2520-2026) |
Abbott Medical
Same company group | 43 | 60 | 53 | 5 | May 12, 2026 (Z-2405-2026) |
Abbott Point Of Care
Same company group | 31 | 22 | 2 | 0 | Apr 1, 2026 (Z-2001-2026) |
Abbott Diagnostics Scarborough
Same company group | 7 | 7 | 7 | 0 | Feb 9, 2026 (Z-1565-2026) |
Abbott Diabetes Care
Same company group | 18 | 40 | 14 | 2 | Nov 24, 2025 (Z-1023-2026) |
Abbott Laboratories
Same company group | 156 | 890 | 161 | 3 | Nov 13, 2025 (Z-0961-2026) |
Abbott Molecular
Same company group | 36 | 19 | 16 | 1 | Apr 28, 2025 (Z-1749-2025) |
Abbott Vascular
Same company group | 42 | 50 | 37 | 0 | Nov 6, 2024 (Z-0733-2025) |
Abbott Diagnostics Technologies
Same company group | 2 | 1 | 1 | 0 | Jun 17, 2024 (Z-2736-2024) |
Thoratec Switzerland
Same company group | 3 | 0 | 2 | 0 | May 22, 2024 (Z-2215-2024) |
Abbott Ireland Limited
Same company group | 1 | 0 | 3 | 0 | Apr 24, 2023 (Z-1696-2023) |
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-3274-2026 | Class II | Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526; Henry Schein, Inc. One Step +… | Aug 20, 2026 |
| Z-3273-2026 | Class II | Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527; McKesson CONSULT hCG… | Aug 20, 2026 |
| Z-3271-2026 | Class II | McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001; Alere hCG Cassette (20 mIU/mL) in… | Aug 20, 2026 |
| Z-3272-2026 | Class II | Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528… | Aug 20, 2026 |
| Z-1702-2024 | Class II | Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170 | Mar 1, 2024 |
| Z-1508-2022 | Class II | The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to measure… | Jun 24, 2022 |
| Z-2475-2019 | Class II | Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes… | Feb 15, 2019 |
| Z-0418-2018 | Class II | Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually… | Nov 14, 2017 |
| Z-0588-2017 | Class II | Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage… | Oct 12, 2016 |
| Z-2778-2016 | Class III | LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam… | Aug 2, 2016 |
| Z-2362-2016 | Class I | Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 99007G3, 99007G5… | Jul 11, 2016 |
| Z-2359-2016 | Class I | Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product Usage: Alere INRatio 2… | Jul 11, 2016 |
| Z-2360-2016 | Class I | Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Product Usage: The… | Jul 11, 2016 |
| Z-2356-2016 | Class I | Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRatio 2 PT Monitoring… | Jul 11, 2016 |
| Z-2355-2016 | Class I | INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Product Usage: The… | Jul 11, 2016 |
| Z-2357-2016 | Class I | Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 Product Usage: The… | Jul 11, 2016 |
| Z-2358-2016 | Class I | Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432, 0200433 Product Usage… | Jul 11, 2016 |
| Z-2354-2016 | Class I | Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product Usage: Alere INRatio ¿… | Jul 11, 2016 |
| Z-2361-2016 | Class I | Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product Usage: The… | Jul 11, 2016 |
| Z-2270-2016 | Class III | Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple test that utilizes an… | Jun 22, 2016 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Dec 10, 2025 | Pomona, CA | Devices | No Action Indicated (NAI) | 2020952 |
| Jan 11, 2019 | San Diego, CA | Devices | Voluntary Action Indicated (VAI) | 1000125596 |
| Jun 5, 2015 | San Diego, CA | Devices | Voluntary Action Indicated (VAI) | 1000125596 |
| Oct 29, 2014 | Pomona, CA | Devices | No Action Indicated (NAI) | 2020952 |
| Jun 27, 2014 | San Diego, CA | Devices | No Action Indicated (NAI) | 1000125596 |
| Jun 27, 2012 | San Diego, CA | Devices | Official Action Indicated (OAI) | 1000125596 |
| Aug 1, 2011 | Pomona, CA | Devices | No Action Indicated (NAI) | 2020952 |
| May 8, 2009 | San Diego, CA | Devices | Voluntary Action Indicated (VAI) | 1000125596 |
| Mar 31, 2009 | Pomona, CA | Devices | No Action Indicated (NAI) | 2020952 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K223179 | Cholestech LDX System | Sep 20, 2023 |
| K151935 | Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere… | Aug 12, 2015 |