Alinity m HCV AMP kit — Class II medical device recall Z-0407-2024
Ongoing recall by Abbott Molecular, Inc., reported 2023-12-06. Abbott has received reports of an increase in reactive negative controls and false positive results in patient
| Recall number | Z-0407-2024 |
|---|---|
| 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 | 2023-10-30 |
| Classified | 2023-11-29 |
| Reported by FDA | 2023-12-06 |
| Quantity | 1,881 units |
| UPC / GTIN / UDI-DI | 00884999047648, 00884999047761 |
| Lot numbers | 381581, 381582, 382447, 382448, 383203, 383204, 385720 |
| Model numbers | 08N50-090, 08N50-095 |
Product
Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System to detect and quantitate hepatitis C virus (HCV) RNA in human serum or plasma.
Reason for recall
Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit.
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-0407-2024. 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.