Recall Z-1479-2024— Abbott GmbH
Class II · Ongoing
Class II FDA medical device recall by Abbott GmbH, initiated 2024-03-04. FDA's recall record names no specific 510(k) clearance for this event. Product: ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35. 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)..
- Recalling firm
- Abbott GmbH
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-03-04
- Firm location
- Wiesbaden, Germany
Product description
ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.