BEUDAMED
    FDA Recall Terminated

    AmpliChip CYP450 Test, CE-IVD, M/N: 4381866190, Roche Molecular Systems, Inc.

    Recall: Z-0735-2007 · Initiated March 9, 2007

    Recall

    Recall Number
    Z-0735-2007
    Event Number
    37585
    Firm
    Roche Molecular Systems, Inc.
    FEI Number
    2243471
    Product Code
    NTI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 9, 2007
    Posted
    April 11, 2007
    Terminated
    August 23, 2007
    Address
    1080 US Highway 202 S, Somerville, NJ, 08876-3733

    Description

    AmpliChip CYP450 Test, CE-IVD, M/N: 4381866190, Roche Molecular Systems, Inc.

    Reason

    The current package insert for the AmpliChip CYP 450 test, lists an incorrect part number for DNase I. The DNase is listed in the "Other Materials Required" section as 'DNase I rec., RNase-free, P/N 04716728001 (Roche Applied Science)" . The Part Number listed for the DNase I listed is incorrect and of lower specific activity than the correct/validated DNase.

    Action

    A product advisory notice was issued on March 9, 2007 to all affiliates, indentifying the problem and listing corrective actions followed by a customer letter (Urgent Medical Device Correction) issued on 3/21/2007, requesting several actions be performed including discontinued use of incorrect DNAse I.

    Distribution

    World wide Distribution --- USA including states of MI, IN, NC, CA KY, IN, VA, and FL.and countries of Netherlands, Germany, Sweden, Denmark, Italy, Spain, Belgium, Switzerland, and Hungary

    Quantity

    89