BEUDAMED
    FDA Enforcement Class II Terminated

    Alinity m Integrated Reaction Units (IRU)

    Recall: Z-0710-2022 · Reported March 9, 2022

    Enforcement

    Recall Number
    Z-0710-2022
    Event ID
    89603
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Molecular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 9, 2022
    Initiation Date
    February 11, 2022
    Classification Date
    March 2, 2022
    Termination Date
    April 14, 2023
    Address
    1300 E Touhy Ave, Des Plaines, IL, 60018-3315, United States

    Description

    Alinity m Integrated Reaction Units (IRU)

    Reason

    There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.

    Code Info

    List Number 09N26-010, Lot Numbers/UDI: 1) 766233 / (01)20884999047864(10)766233(11)210614(240)09N26-010 2) 770433 / (01)20884999047864(10)770433(11)210621(240)09N26-010 3) 771200 / (01)20884999047864(10)771200(11)210712(240)09N26-010 4) 771201 / (01)20884999047864(10)771201(11)210719(240)09N26-010 5) 773642 / (01)20884999047864(10)773642(11)210723(240)09N26-010

    Distribution

    US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, GA, IL, KY, LA, MA, MI, MO, NC, NJ, NY, OK, RI, SD, TX, WA, and WI.

    Quantity

    3063 kits