BEUDAMED
    FDA Recall Terminated

    Seradyn QMS Vancomycin reagents, Part Number: 0373589. Seradyn, Inc, Indianapolis, IN.

    Recall: Z-1102-2008 · Initiated December 20, 2007

    Recall

    Recall Number
    Z-1102-2008
    Event Number
    46150
    Firm
    Seradyn, Inc.
    FEI Number
    3002513423
    Product Code
    LEH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 20, 2007
    Posted
    April 29, 2008
    Terminated
    December 30, 2008
    Address
    7998 Georgetown Rd, Indianapolis, IN, 46268-5631

    Description

    Seradyn QMS Vancomycin reagents, Part Number: 0373589. Seradyn, Inc, Indianapolis, IN.

    Reason

    False negative test results due to Interfering substances (heterophile antibodies) in the patient's blood may produce erroneously low results.

    Action

    Consignees were notified of the problem via Urgent Medical Device Correction letter dated 12/20/07. The letter provided information on the issues concerning the recall. The firm will revise the package insert to address the potential occurrence of false negative bias. If inconsistencies with Vancomycin level exist, confirm with an alternative test method. For further information please contact 1-800-428-4072.

    Distribution

    Worldwide Distribution --- USA including states of California and New York, and countries of Australia, Belgium, Canada, Finland, Germany, Ireland, Japan, Spain and United Kingdom.

    Quantity

    1,819 kits plus bulk material for 1,863 kits.