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Abbott GmbH Recall 94205

Description: ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35

Abbott GmbH Recall 94205 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1479-2024
Event ID94205
Event DescriptionARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
Product TypeDevices
DistributionUS Nationwide distribution.
Quantity7219 units
Recall ReasonCustomer 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).
Device Classification20240410
Device Code Infoa) 1L79-25, 00380740001414, Lot Numbers: 52011BE00, 54140BE00, 56375BE00, 58163BE00, 59194BE00; b) 1L79-35, 00380740001421, Lot Numbers: 52015BE00, 54144BE00, 56379BE00, 58167BE00, 59198BE00
Center Classification Date20240404
Recall Initiation Date20240304
Recalling FirmAbbott GmbH
Initial Notification Letter
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