BEUDAMED
    FDA Recall Terminated

    Vitros Chemistry CRBM Slides, REF 889 2382. There are 90 slides per box. For in vitro diagnostic use. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626.

    Recall: Z-1016-05 · Initiated May 26, 2005

    Recall

    Recall Number
    Z-1016-05
    Event Number
    32303
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    KLT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 26, 2005
    Posted
    July 16, 2005
    Terminated
    June 12, 2006
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    Vitros Chemistry CRBM Slides, REF 889 2382. There are 90 slides per box. For in vitro diagnostic use. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626.

    Reason

    Falsely elevated Carbamazepine results.

    Action

    Letters dated 5/26/05 with instructions to discontinue use and discard slides. Customers also instructed to review previous results with Laboratory Medical Director to determine need for further consultation with health care provider.

    Distribution

    423 U.S. consignees nationwide, and 22 OCD/J&J foreign affiliates (Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Peru, Ecuador, India, Japan, Mexico, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain)

    Quantity

    5,846 boxes