FDA Device recall Z-1480-2024
Alinity i Anti-HCV Reagent Kit, List Number 08P0521
- FDA Device
- Class II
- ongoing
- Published 2024-04-10
On 2024-04-10 the FDA classified a Class II recall of Alinity i Anti-HCV Reagent Kit, List Number 08P0521 by Abbott, citing customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1480-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-04 |
| Published | 2024-04-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Abbott |
| Distribution | US |
Product
Alinity i Anti-HCV Reagent Kit, List Number 08P0521
Reason
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).
Identifiers
| code_info | UDI/DI 00380740130657, Lot Numbers: 52020BE00, 54149BE00, 56384BE00, 58172BE00, 59203BE00 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1480-2024%22
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