BEUDAMED
    FDA Recall Terminated

    Vitros Immunodiagnostic Products CK-MB REAGENT PACK, REF 189 6836, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK.

    Recall: Z-0298-04 · Initiated November 26, 2003

    Recall

    Recall Number
    Z-0298-04
    Event Number
    27905
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    JHX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 26, 2003
    Posted
    January 6, 2004
    Terminated
    February 20, 2004
    Address
    100 Indigo Creek Drive, Rochester, NY, 14650-0881

    Description

    Vitros Immunodiagnostic Products CK-MB REAGENT PACK, REF 189 6836, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK.

    Reason

    Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results.

    Action

    Customers notified via phone and faxed letter on 11/26/03. Customers provided with a modified QC procedure to be used until new shipments can be made.

    Distribution

    738 reagent packs shipped to U.S. consignees and 36 reagent packs to Canadian consignees.

    Quantity

    774 reagent packs