Alinity m System — Class II medical device recall Z-0460-2022
Ongoing recall by Abbott Molecular, Inc., reported 2022-01-12, distributed nationwide. There is a potential for abnormal (non-sigmoidal) amplification curves.
| Recall number | Z-0460-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| 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 |
| Distributed | Nationwide (US) |
| 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 |
| Model numbers | 08N53-002 |
Product
Alinity m System, Part No. 08N53-002
Reason for recall
There is a potential for abnormal (non-sigmoidal) amplification curves.
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-0460-2022. 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.