BEUDAMED
    FDA Recall Open, Classified

    Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096

    Recall: Z-0739-2023 · Initiated November 22, 2022

    Recall

    Recall Number
    Z-0739-2023
    Event Number
    91202
    Firm
    Abbott Molecular, Inc.
    FEI Number
    3005248192
    Product Code
    QJR
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 22, 2022
    Posted
    December 20, 2022
    Address
    1300 E Touhy Ave, Des Plaines, IL, 60018-3315

    Description

    Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096

    Reason

    Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.

    Action

    Abbott Molecular issue an Urgent Field Safety Notice /Field Correction Recall to its consignees on 11/22/2022 by FedEx priority express. The notice explained the issue and requested the following actions: "- Discard inventory of any lots listed in Appendix A below. Contact Abbott Customer Support for credit of any unused kit(s). - If you have forwarded any kits of these lots 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 1-800-55-7042 Option 2."

    Distribution

    Worldwide

    Quantity

    3896 kits