BEUDAMED
    FDA Enforcement Class II Ongoing

    Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.

    Recall: Z-1349-2023 · Reported April 12, 2023

    Enforcement

    Recall Number
    Z-1349-2023
    Event ID
    91777
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abbott Molecular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    April 12, 2023
    Initiation Date
    November 11, 2022
    Classification Date
    April 6, 2023
    Address
    1300 E Touhy Ave, Des Plaines, IL, 60018-3315, United States

    Description

    Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.

    Reason

    The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This would result in a potential for delay of results and incorrect results.

    Code Info

    Alinity m System Serial #01015, UDI: (01)00884999048034(11)220505(21)01015(240)08N53-002; ADU Serial #AMP05139.

    Distribution

    US Distribution to state of: PA, a government account.

    Quantity

    1