BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-1479-2024 · Reported April 10, 2024

    Enforcement

    Recall Number
    Z-1479-2024
    Event ID
    94205
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abbott GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 10, 2024
    Initiation Date
    March 4, 2024
    Classification Date
    April 4, 2024
    Address
    Max-Planck-Ring 2, Wiesbaden, N/A, Germany

    Description

    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).

    Code Info

    a) 1L79-25, 00380740001414, Lot Numbers: 52011BE00, 54140BE00, 56375BE00, 58163BE00, 59194BE00; b) 1L79-35, 00380740001421, Lot Numbers: 52015BE00, 54144BE00, 56379BE00, 58167BE00, 59198BE00

    Distribution

    US Nationwide distribution.

    Quantity

    7219 units