BEUDAMED
    FDA Enforcement Class II Ongoing

    Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection and differentiation of RNA from influenza A virus (flu A), influenza B virus (flu B), Respiratory Syncytial Virus (RSV), and SARS-CoV-2 in nasopharyngeal (NP) swab specimens collected by a healthcare provider, from individuals with signs and symptoms of respiratory tract infection

    Recall: Z-1748-2025 · Reported May 21, 2025

    Enforcement

    Recall Number
    Z-1748-2025
    Event ID
    96790
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abbott Molecular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 21, 2025
    Initiation Date
    April 28, 2025
    Classification Date
    May 12, 2025
    Address
    1300 E Touhy Ave, Des Plaines, IL, 60018-3315, United States

    Description

    Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection and differentiation of RNA from influenza A virus (flu A), influenza B virus (flu B), Respiratory Syncytial Virus (RSV), and SARS-CoV-2 in nasopharyngeal (NP) swab specimens collected by a healthcare provider, from individuals with signs and symptoms of respiratory tract infection

    Reason

    There were reports of an increase in reactive negative controls and false positive results.

    Code Info

    UDI-DI: 00884999049338; Lot Numbers: 409383 410627 411921

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    1447 units