Abbott Alinity m System — Class II medical device recall Z-1349-2023
Ongoing recall by Abbott Molecular, Inc., reported 2023-04-12. The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Dete
| Recall number | Z-1349-2023 |
|---|---|
| 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 | 2022-11-11 |
| Classified | 2023-04-06 |
| Reported by FDA | 2023-04-12 |
| Quantity | 1 |
| UPC / GTIN / UDI-DI | 00884999048034 |
| Serial numbers | 01015, AMP05139 |
| Model numbers | 08N53-002 |
Product
Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
Reason for recall
The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This would result in a potential for delay of results and incorrect 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-1349-2023. 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.