Alinity m System — Class II medical device recall Z-0462-2022
Terminated recall by Abbott Molecular, Inc., reported 2022-01-12. There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.
| Recall number | Z-0462-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Molecular, Inc., Des Plaines, IL, United States |
| Recall initiated | 2021-12-06 |
| Classified | 2022-01-06 |
| Reported by FDA | 2022-01-12 |
| Terminated | 2026-08-14 |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CL, CO, CZ, DE, EE, EG, ES, FI, FR, GB, HK, IE, IL, IT, JP, KR, MA, MX, MY, NL, NO, NZ, PK, PL, PT, RO, RU, SA, SE, SG, SI, SV, TH, TW, VN, ZA |
| Quantity | 742 devices |
| Reason classes | software |
| Model numbers | 08N53-002 |
Product
Alinity m System, Part No. 08N53-002
Reason for recall
There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.
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-0462-2022. 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.