BEUDAMED
    FDA Recall Terminated

    IMx HAVAB Controls are for In Vitro Diagnostic use. The kit is composed of 2 bottles of Negative and Positive controls of 9 mL each. These are prepared with recalcified human plasma and the preservative is Sodium Azide. The Negative Control is non-reactive for HbsAG, HIV-1, Anti-HCV, anti-HiV-1/HIV-2 and IgG antibody against HAV. The Positive Control is recalcified human plasma for anti-HAV diluted with Negative Control.

    Recall: Z-0217-05 · Initiated October 27, 2004

    Recall

    Recall Number
    Z-0217-05
    Event Number
    30388
    Firm
    Abbott Health Products, Inc.
    FEI Number
    2623532
    Product Code
    LOL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 27, 2004
    Posted
    November 20, 2004
    Terminated
    March 16, 2005
    Address
    Hwy 2 Km 58.0, Barceloneta, PR, 00617

    Description

    IMx HAVAB Controls are for In Vitro Diagnostic use. The kit is composed of 2 bottles of Negative and Positive controls of 9 mL each. These are prepared with recalcified human plasma and the preservative is Sodium Azide. The Negative Control is non-reactive for HbsAG, HIV-1, Anti-HCV, anti-HiV-1/HIV-2 and IgG antibody against HAV. The Positive Control is recalcified human plasma for anti-HAV diluted with Negative Control.

    Reason

    Abbott identified through investigational studies that IMx HAVAB Controls lot 18220Q100 is generating Negative Control values outside the upper range specified in the IMx HAVAB Package Insert.

    Action

    Device recall letters were dated 10/27/2004. Letter was mail to customers asking to destroy and discontinue use of device. On hand inventory information was requested to be forward to Abbott at 1-800-777-0051 (U.S. only).

    Distribution

    The product has been distributed to hospitals, laboratories and other institution including government accounts. Geographic areas of distribution include Puerto Rico, Canada, Germany, Thailand and U.S.A. Government accounts includes: VA Medical Center, Saint Louise, MO; Brecksville VA Hosp. Supp, Brecksville, OH; VA MED CENTER, Phoenix, AZ; Department Veterinary Affair Med., Houston, TX; VA Med., Cincinnati, OH; VA Med Center, Seattle, WA; Truman Mem. VA, Columbia, MO; Dept. Vet. Aff., Shreveport, LA; VA Hosp. Whse., Fresno, CA ; VA Med Center, Omaha, NE ; VA Med. Center, Lexington, KY; VA Med Center, Detroit, MI ; VA Hosp., San Diego, CA ; Naval Hosp., Great Lakes, IL; VA Med. Center, San Francisco, CA.

    Quantity

    397 kits