Device product
Alinity i Anti-HCV Reagent Kit, List Number 08P0521
Z-1480-2024
Product summary
- Firm
- Abbott GmbH
- Event
- Event 94205
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5110 units
- Official record key
device-enforcement:Z-1480-2024
Official wording
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).
Code information: UDI/DI 00380740130657, Lot Numbers: 52020BE00, 54149BE00, 56384BE00, 58172BE00, 59203BE00
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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).