BEUDAMED
    FDA Recall Terminated

    Abbott Commander Flexible Pipetting Center (FPC) Operations Manual, list 6A97-27; Abbott Laboratories, Abbott Park, IL 60064

    Recall: Z-0297-04 · Initiated December 2, 2003

    Recall

    Recall Number
    Z-0297-04
    Event Number
    27898
    Firm
    Abbott Laboratories HPD/ADD/GPRD
    FEI Number
    1415939
    Product Code
    JQW--
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 2, 2003
    Posted
    July 20, 2004
    Terminated
    July 20, 2004
    Address
    100/200 Abbott Park Road, Abbott Park, IL, 60064

    Description

    Abbott Commander Flexible Pipetting Center (FPC) Operations Manual, list 6A97-27; Abbott Laboratories, Abbott Park, IL 60064

    Reason

    The Operations Manual has the wrong Farenheit temperature range listed (102-122) instead of (104-122) for the preparation of the Terg-A-Zyme solution used to clean pipettes of the Abbott Commander Flexible Pipetting Center.

    Action

    Abbott sent 'Important Product Information' letters dated 12/2/03 to the end user accounts, advising them of the error in conversion of the Celsius temperature range to Farenheit in the first step in preparing the Terg-A-Zyme cleaning solution. The letter listed the entire corrected solution preparation procedure and advised the accounts to retain the letter with the Abbott FPC Operations Manual for future reference.

    Distribution

    Nationwide and internationally through Abbott affiliates in Colombia, Brazil, Puerto Rico, Japan, Singapore, Hong Kong and Germany.