Abbott Alinity m Resp-4-Plex Amp Kit — Class II medical device recall Z-0739-2023
Ongoing recall by Abbott Molecular, Inc., reported 2022-12-28. Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M
| Recall number | Z-0739-2023 |
|---|---|
| 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 | 2022-11-22 |
| Classified | 2022-12-20 |
| Reported by FDA | 2022-12-28 |
| Quantity | 3,896 kits |
| Lot numbers | 2/8/20231499, 381465, 524433, 526710, 527845 |
| Model numbers | 09N79-096 |
| Expiration dates | 2023-01-05, 2023-01-21, 2023-08-24 |
Product
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
Reason for recall
Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
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-0739-2023. 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.