BEUDAMED
    FDA Recall Open, Classified

    Alinity i Anti-TPO Reagent Kit, List Number 09P3521

    Recall: Z-1696-2023 · Initiated April 24, 2023

    Recall

    Recall Number
    Z-1696-2023
    Event Number
    92271
    Firm
    Abbott Ireland Limited Finisklin Business & Technology Park Sligo Ireland
    FEI Number
    3008344661
    Product Code
    JZO
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 24, 2023
    Posted
    June 8, 2023

    Description

    Alinity i Anti-TPO Reagent Kit, List Number 09P3521

    Reason

    Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU).

    Action

    On April 24, 2023, Abbott issued a Product Correction letter, via FedEx priority overnight express, for this issue. Customers were instructed to provide a copy of the Product Correction letter to the laboratory manager, supervisor or health professional responsible for the impacted product and to complete and return the Customer Reply form.

    Distribution

    US Nationwide distribution in the states of CA, CO, FL, GA, IL, KY, LA, MD, MI, MN, NJ, NY, OH, RI, SC, SD, TN, TX, WA. No international distribution of affected lot.

    Quantity

    110 kits