Alinity m SARS-CoV-2 Amp Kit — Class I medical device recall Z-0006-2022
Terminated recall by Abbott Molecular, Inc., reported 2021-10-20, distributed nationwide. There is a potential for false positive results.
| Recall number | Z-0006-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Molecular, Inc., Des Plaines, IL, United States |
| Recall initiated | 2021-09-02 |
| Classified | 2021-10-14 |
| Reported by FDA | 2021-10-20 |
| Terminated | 2024-07-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CO, CZ, DE, EE, ES, FI, FR, GB, HK, IE, IL, IT, JP, KR, MY, NL, NO, NZ, PL, PT, RO, SA, SE, SG, SI, TH, TW, VN, ZA |
| Quantity | 71,314 units |
| UPC / GTIN / UDI-DI | 00884999049222, 00884999050211 |
| Serial numbers | 511468, 511504, 511505, 512025, 512416, 512417, 512705, 512712, 512898, 513147, 513629, 514359, 514762, 515053, 515415, 515416, 515948, 516084, 516430, 516431, 516612, 516636, 516910, 516911, 517009 and 25 more |
Product
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Reason for recall
There is a potential for false positive results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0006-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.