ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
Published April 10, 2024 · Recall initiated: March 4, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott GmbH
- Distributor
- US Nationwide distribution.
- Lot
- a) 1L79-25, 00380740001414, Lot Numbers: 52011BE00, 54140BE00, 56375BE00, 58163BE00, 59194BE00; b) 1L79-35, 00380740001421, Lot Numbers: 52015BE00, 54144BE00, 56379BE00, 58167BE00, 59198BE00
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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