BEUDAMED
    FDA Recall Terminated

    CA 15-3 Controls, list 9C08-10; an In Vitro diagnostic for use with the AxSYM or IMx CA 15-3 reagents, calibrators and instruments; each kit contains 2 bottles with 115D8:DF3 reactive determinants (human) prepared in TRIS buffer with protein (bovine) stabilizers to yield the following assay values (U/ml): Control L - 35 and Control H - 150; Abbott Laboratories, Abbott Park, IL 60064

    Recall: Z-1244-06 · Initiated June 9, 2006

    Recall

    Recall Number
    Z-1244-06
    Event Number
    35627
    Firm
    Abbott Laboratories MPG
    FEI Number
    1415939
    Product Code
    MOI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 9, 2006
    Posted
    July 18, 2006
    Terminated
    January 18, 2008
    Address
    100 Abbott Park Rd, Abbott Park, IL, 60064-3502

    Description

    CA 15-3 Controls, list 9C08-10; an In Vitro diagnostic for use with the AxSYM or IMx CA 15-3 reagents, calibrators and instruments; each kit contains 2 bottles with 115D8:DF3 reactive determinants (human) prepared in TRIS buffer with protein (bovine) stabilizers to yield the following assay values (U/ml): Control L - 35 and Control H - 150; Abbott Laboratories, Abbott Park, IL 60064

    Reason

    The CA 15-3 Controls replicates out of range high resulting in invalid runs.

    Action

    Abbott initiated a field correction recall by letter dated 6/9/06 and sent on 6/12/06 to all customers receiving the affected controls. The accounts were informed of the increase in invalid runs due to controls outside of the package insert range with this lot of CA 15-3 Controls. The accounts were requested to assess the inventory for the affected lot of controls, discontinue use of the lot and destroy the remaining inventory of the lot, recording the number of kits on the customer reply form and faxing it to Abbott by 6/21/06, indicating that the letter was received and understood. Credit will be issued for the number of kits destroyed, as indicated on the reply sheet. Customers requiring additional information were directed to contact Abbott Customer Service at 1-877-422-2688.

    Distribution

    Worldwide, including U.S.A., Puerto Rico, Canada, Mexico, Ecuador, Chile, Argentina, Brazil, Germany, Japan, SIngapore, Hong Kong, Thailand, South Korea and Australia.

    Quantity

    1794 kits