The Alinity m System — Class II medical device recall Z-1518-2022
Completed recall by Abbott Molecular, Inc., reported 2022-08-24. Incorrect optical calibration
| Recall number | Z-1518-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Molecular, Inc., Des Plaines, IL, United States |
| Recall initiated | 2022-07-19 |
| Classified | 2022-08-12 |
| Reported by FDA | 2022-08-24 |
| Countries outside the US | IT |
| Quantity | 1 |
| Serial numbers | 00654 |
| Model numbers | 08N53-002 |
Product
The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
Reason for recall
Incorrect optical calibration
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-1518-2022. 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.