BEUDAMED
    FDA Enforcement Class II Terminated

    Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121

    Recall: Z-0666-2019 · Reported January 2, 2019

    Enforcement

    Recall Number
    Z-0666-2019
    Event ID
    81632
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Ireland Diagnostics Division
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 2, 2019
    Initiation Date
    November 21, 2018
    Classification Date
    December 22, 2018
    Termination Date
    April 1, 2021
    Address
    Lisnamuck, Co. Longford, N/A, Ireland

    Description

    Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121

    Reason

    Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.

    Code Info

    UDI/Lot Numbers (01)00380740160616 (17)190807(10)92056UI00 / 92056UI00

    Distribution

    AR, FL, GA, MD, OK, VA

    Quantity

    27 units