Device product
ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
Z-1479-2024
Product summary
- Firm
- Abbott GmbH
- Event
- Event 94205
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7219 units
- Official record key
device-enforcement:Z-1479-2024
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: a) 1L79-25, 00380740001414, Lot Numbers: 52011BE00, 54140BE00, 56375BE00, 58163BE00, 59194BE00; b) 1L79-35, 00380740001421, Lot Numbers: 52015BE00, 54144BE00, 56379BE00, 58167BE00, 59198BE00
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).