BEUDAMED
    FDA Enforcement Class II Ongoing

    Alinity m HBV AMP Kit (US and CE)

    Recall: Z-0884-2022 · Reported April 13, 2022

    Enforcement

    Recall Number
    Z-0884-2022
    Event ID
    89757
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abbott Molecular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 13, 2022
    Initiation Date
    March 4, 2022
    Classification Date
    April 6, 2022
    Address
    1300 E Touhy Ave, Des Plaines, IL, 60018-3315, United States

    Description

    Alinity m HBV AMP Kit (US and CE)

    Reason

    There is a potential for misquantitation high results for negative samples.

    Code Info

    List Numbers: 1) 08N47-095 (US); Lots: 519756, 523799, and 524361, Updated to add: 381583, 529391, 529687, 530273, 531598; 2) 08N47-090 (CE); Lots: 519755, 520957, 522137, 523798, and 524059, Updated to add: 380963, 380979, 381021, 529378, 529686, 530272, 531189, 531596

    Distribution

    US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS consignees - Australia, Austria, Belgium, Brazil, Canada, Columbia, Czech Republic, El Salvador, Estonia, France, Germany, Israel, Italy, Japan, Latvia, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam

    Quantity

    4966 kits, updated 101/17/2023