BEUDAMED
    FDA Recall Terminated

    Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use.

    Recall: Z-0023-2007 · Initiated September 7, 2006

    Recall

    Recall Number
    Z-0023-2007
    Event Number
    36405
    Firm
    Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila
    FEI Number
    2623532
    Product Code
    JIS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 7, 2006
    Posted
    October 12, 2006
    Terminated
    September 9, 2011
    Address
    Barceloneta, PR, 00617-3009

    Description

    Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use.

    Reason

    Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators listed in this recall. The investigation to date has shown that both controls and patient results have shifted upwards over time together.

    Action

    The Device Recall Letter dated September 07, 2006, and Customer Reply Form was sent via Federal Express Priority mail to all customers who received the affected lots.

    Distribution

    Worldwide, including USA, Puerto Rico, Canada, Mexico, Guatemala, Costa Rica, Venezuela, Colombia, Ecuador, Chile, Uruguay, Argentina, Brazil, Dominican Republic, El Salvador, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, South Korea, Australia, Honduras, Trinidad-Tobago, St. Vincent, Bahamas, Panama, and Cayman Islands.

    Quantity

    797