BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated April 28, 2025

    Recall

    Recall Number
    Z-1748-2025
    Event Number
    96790
    Firm
    Abbott Molecular, Inc.
    FEI Number
    3005248192
    Product Code
    QJR
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 28, 2025
    Posted
    May 12, 2025
    Address
    1300 E Touhy Ave, Des Plaines, IL, 60018-3315

    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.

    Action

    An Urgent Field Safety Notice/ Field Correction Recall notification letter dated 4/24/25 was sent to customers. Necessary Actions: " Discard inventory of the lot listed in the above table. Contact Abbott Customer Support for replacement of any unused kit(s). " If you have forwarded any kits of this lot to other laboratories, please inform them of this Urgent Field Safety Notice / Field Correction Recall and provide a copy of this letter. " Return the associated Customer Reply form. Please review this information with laboratory personnel and retain this communication for future reference. If you have any questions regarding this communication, please contact your local Abbott representative, or call Abbott Technical Support at 1-800-553-7042 Option 2. We apologize for any inconvenience this may have caused your laboratory.

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    1447 units