Abbott GmbH: Alinity i Anti-HCV Reagent Kit, List Number 08P0521

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).

Details from the source

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). Distribution: US Nationwide distribution. Quantity: 5110 units Lot/code info: UDI/DI 00380740130657, Lot Numbers: 52020BE00, 54149BE00, 56384BE00, 58172BE00, 59203BE00

UPC codes

00380740130657

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.