BEUDAMED
    FDA Recall Terminated

    VITROS VALP Reagent , REF 680 1710. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests. Responsible firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, N.Y. 14626.

    Recall: Z-0866-05 · Initiated April 18, 2005

    Recall

    Recall Number
    Z-0866-05
    Event Number
    31942
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    LEG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 18, 2005
    Posted
    June 4, 2005
    Terminated
    October 13, 2005
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    VITROS VALP Reagent , REF 680 1710. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests. Responsible firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, N.Y. 14626.

    Reason

    Negatively biased results may be observed when the reagent is stored on the VITROS 5,1FS Chemistry System for less than seven days.

    Action

    Letters dated 4/18/2005 with instructions to process a mid-level QC fluid every eight hours when processing patient samples for valproic acid. Replacement product to be shipped as soon as available.

    Distribution

    37 U.S. consignees nationwide. Ortho-Clinical foreign affiliates in England, France and Spain.

    Quantity

    139 boxes