BEUDAMED
    FDA Recall Terminated

    CA 125 Controls, list 9C22-10; Abbott Laboratories, Abbott Park, IL 60064

    Recall: Z-0322-04 · Initiated November 25, 2003

    Recall

    Recall Number
    Z-0322-04
    Event Number
    27834
    Firm
    Abbott Laboratories HPD/ADD/GPRD
    FEI Number
    1415939
    Product Code
    LTK--
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 25, 2003
    Posted
    January 10, 2004
    Terminated
    July 26, 2004
    Address
    100/200 Abbott Park Road, Abbott Park, IL, 60064

    Description

    CA 125 Controls, list 9C22-10; Abbott Laboratories, Abbott Park, IL 60064

    Reason

    The CA 125 assay product inserts list the incorrect storage instructions for the CA 125 Calibrators and Controls, and the product information letter (PI-P) shipped with the products to correct the storage conditions, 69-6349/R2, refers to an outdated control package insert, 39-1642/R3, instead of the current control package insert 34-1047/R4

    Action

    Field Correction recall by letter dated 11/25/03 to all customers receiving the affected reagents. The accounts were informed of the incorrect control package insert referenced in the product information letter shipped with each CA 125 product. The letters contained the correct control package insert number, 34-1047/R4, and stated that all CA 125 assay product inserts will be updated shortly to include the revised storage instructions for the CA 125 Calibrators and Controls.

    Distribution

    Nationwide and internationally through Abbott subsidiaries in Argentina, Aruba, Australia, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Peru, Hong Kong, India, Jamaica, Japan, Korea, New Zealand, Pakistan, Puerto Rico, Singapore, Taiwan, Thailand, United Kingdom and Uruguay.