BEUDAMED
    FDA Recall Terminated

    AFP Control Kit distributed under the following label: AxSYM and IMx, Abbott Laboratories USA, North Chicago, IL 60064

    Recall: Z-0627-03 · Initiated December 13, 2002

    Recall

    Recall Number
    Z-0627-03
    Event Number
    25554
    Firm
    Abbott Health Products, Inc.
    FEI Number
    2623532
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 13, 2002
    Posted
    March 6, 2003
    Terminated
    June 2, 2004
    Address
    Hwy 2 Km 58.0, Barceloneta, PR, 00617

    Description

    AFP Control Kit distributed under the following label: AxSYM and IMx, Abbott Laboratories USA, North Chicago, IL 60064

    Reason

    Results lower than package insert ranges

    Action

    Device Recall Letters were mailed to all Abbott customers World Wide on 12/11/02. The letter instructed to check their inventory for the recalled product, discontinue use and destroy it according to their laboratory procedures. If the product was forwarded to another laboratory, please provide them with a copy of the letter.

    Distribution

    Distribution nationwide and Japan, Singapore, Australia, New Zealand, and Great Britain

    Quantity

    826 kits