Alinity i Anti-HCV Reagent Kit — Class II medical device recall Z-1480-2024
Ongoing recall by Abbott GmbH, reported 2024-04-10, distributed nationwide. Customer complaints were received regarding falsely elevated results for some patient samples. Internal studie
| Recall number | Z-1480-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott GmbH, Wiesbaden, Germany |
| Recall initiated | 2024-03-04 |
| Classified | 2024-04-04 |
| Reported by FDA | 2024-04-10 |
| Distributed | Nationwide (US) |
| Quantity | 5,110 units |
| UPC / GTIN / UDI-DI | 00380740130657 |
| Lot numbers | 52020BE00, 54149BE00, 56384BE00, 58172BE00, 59203BE00 |
Product
Alinity i Anti-HCV Reagent Kit, List Number 08P0521
Reason for recall
Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79). " Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).
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-1480-2024. 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.