BEUDAMED
    FDA Recall Terminated

    AxSYM Total B-hCG Reagent Pack

    Recall: Z-1436-04 · Initiated July 7, 2004

    Recall

    Recall Number
    Z-1436-04
    Event Number
    29623
    Firm
    Abbott Health Products, Inc.
    FEI Number
    2623532
    Product Code
    JHI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 7, 2004
    Posted
    September 2, 2004
    Terminated
    December 1, 2004
    Address
    Hwy 2 Km 58.0, Barceloneta, PR, 00617

    Description

    AxSYM Total B-hCG Reagent Pack

    Reason

    Complaints have been received for AxSYM Total B-hCG Reagents lots 17202Q100, 17556Q100 and 17387Q100 failing calibrations.

    Action

    Device recall letters dated 7/7/04 were sent to all customers. Customers were instructed to identify if they have used, are currently using, or have inventory of the AxSYM Total B-hCG Reagent lots. Discontinue use of and destroy any remaining inventory of the lots according to their laboratory procedures. Record the quantity currently in their facility that will be destroyed on the attached reply form and fax the form to Abbott at 1-800-777-0051 (U.S. only). Follow their laboratory''s procedure for communicating this issue to the health care providers they serve.

    Distribution

    Distribution was nationwide to Laboratories and to the following government accounts: Logistic Div USAMEDAC Lab, Fort Drum, NY Keller Army Hospital Med Sup, West Point, NY VA MED CTR SUP SRV, Milwaukee, WI Weed Army Comm Hosp Lab, Fort Irwin, CA Shaw AFB 20th MDSS SGSL, Shaw AFB, SC Contr Officer, Lemoore, CA Naval Hosp, Pensacola, FL MEDCL CTR FED Prisoners, Springfield, MO Foreign countries: Japan, Singapore, Australia, New Zealand, Dominican Republic, San Salvador, Pakistan, Thailand, Honduras, Canada, Taiwan and Ge

    Quantity

    5617 kits