BEUDAMED
    FDA Recall Terminated

    VITEK GPS-106 Gram Positive Susceptibility Card, Catalog #V4335, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC and bioMerieux sa, France.

    Recall: Z-0725-04 · Initiated January 15, 2004

    Recall

    Recall Number
    Z-0725-04
    Event Number
    28429
    Firm
    bioMerieux Inc
    FEI Number
    1950204
    Product Code
    LON
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 15, 2004
    Posted
    July 20, 2004
    Terminated
    November 24, 2004
    Address
    595 Anglum Rd, Hazelwood, MO, 63042-2320

    Description

    VITEK GPS-106 Gram Positive Susceptibility Card, Catalog #V4335, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC and bioMerieux sa, France.

    Reason

    The cards were stamped with an incorrect card code that causes the system to read and analyze the cards incorrectly.

    Action

    The firm issued recall letters dated 1/15/04 via regular mail requesting remaining inventories be destroyed and explaining the method which the customer can use to confirm the cards were not misreported. The firm also issued a 'Second Notification' recall letter dated 3/9/04.

    Distribution

    Distribution was nationwide to medical facilities, including V.A. and military customers. There was no foreign distribution.

    Quantity

    1,955/20-card boxes