BEUDAMED
    FDA Recall Terminated

    VITEK GPS-107Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC.

    Recall: Z-0721-04 · Initiated January 28, 2004

    Recall

    Recall Number
    Z-0721-04
    Event Number
    28431
    Firm
    bioMerieux Inc
    FEI Number
    1950204
    Product Code
    LON
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 28, 2004
    Posted
    July 20, 2004
    Terminated
    April 18, 2005
    Address
    595 Anglum Rd, Hazelwood, MO, 63042-2320

    Description

    VITEK GPS-107Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC.

    Reason

    Some of the cards were stamped with an incorrect card code causing the system to read and report the cards incorrectly.

    Action

    The firm issued recall letters dated 1/28/04 via regular mail requesting remaining inventories be destroyed and explaining the method which the customer can use to confirm the cards were not misreported. A 'Second Notification' recall letter was issued dated 3/9/04.

    Distribution

    Distribution was made nationwide to medical facilities, which includes military and government consignees. Distribution was also made to foreign consignees located in Colombia, Costa Rica, and China.

    Quantity

    1,988/20-card boxes