BEUDAMED
    FDA Recall Terminated

    Envoy 500 Serum Control Kit. The device is used for monitoring the performance of clinical chemistry methods within the clinical range.

    Recall: Z-1233-2010 · Initiated December 4, 2009

    Recall

    Recall Number
    Z-1233-2010
    Event Number
    54279
    Firm
    Vital Diagnostics, Inc.
    FEI Number
    1717966
    Product Code
    JJY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 4, 2009
    Posted
    April 6, 2010
    Terminated
    July 25, 2012
    Address
    27 Wellington Rd, Lincoln, RI, 02865-4411

    Description

    Envoy 500 Serum Control Kit. The device is used for monitoring the performance of clinical chemistry methods within the clinical range.

    Reason

    Vital Diagnostics observed a bias in the Quality Control Consensus Program between published values for ALP on the ATAC 8000 and reported customer means. The ranges were adjusted to reflect the analyzer population.

    Action

    Customers were mailed copies of Technical Bulletin 8100 and 5024 dated September 30, 2009 which advised of the Alkaline Phosphatase QC value revisions for the Envoy 500 and the ATAC 8000. If you have any questions, please contact Vital Diagnostics Technical Support at 1-800-345-2822.

    Distribution

    Nationwide.

    Quantity

    871 Kits