BEUDAMED
    FDA Recall Terminated

    Vitros Immunodiagnostic Products TROPONIN I Reagent Packs, (Lot 1110 and 1130 REF #194 9882 and Lot 2510 and 2530 REF #680 1857). Each reagent pack contains 100 coated wells. Firm on label: Ortho-Clinical Diagnostics, Amersham UK.

    Recall: Z-1053-04 · Initiated June 7, 2004

    Recall

    Recall Number
    Z-1053-04
    Event Number
    29394
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    MMI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 7, 2004
    Posted
    July 20, 2004
    Terminated
    April 18, 2005
    Address
    100 Indigo Creek Drive, Rochester, NY, 14626-5101

    Description

    Vitros Immunodiagnostic Products TROPONIN I Reagent Packs, (Lot 1110 and 1130 REF #194 9882 and Lot 2510 and 2530 REF #680 1857). Each reagent pack contains 100 coated wells. Firm on label: Ortho-Clinical Diagnostics, Amersham UK.

    Reason

    Random occurrence of false positive test results.

    Action

    Domestic: Phone calls on 6/7-8/2004. Recall letters sent Federal Express on 6/7/2004. Foreign affiliates notified via e-mail on 6/7/2004. Customers instructed to discard inventory and notify health care providers. EXPANDED: Domestic: 7/1/2004 phone calls and faxes to consignees. FED EX letters mailed on 7/2/2004. Foreign affiliates notified via email on 6/30/2004.

    Distribution

    4,665 reagent packs shipped to domestic customers nationwide, including 8 federal government accounts (contract #V797P-6565A). 520 reagent packs shipped to 22 foreign affiliates who further distributed the product to: Asia Pacific, Canada, Caribbean, Chile, China, France, Germany, Italy, Mexico, Spain, UK and Northern Europe. EXPANDED: 440 reagent packs shipped to 13 domestic customers and 1,067 reagent packs shipped to 22 foreign affiliates.

    Quantity

    5,185 reagent packs (6/7/04) & 1,507 reagent packs (6/30/04)