BEUDAMED
    FDA Recall Terminated

    Sure-Vue HSV-2 Rapid Test, Catalogue No: 23-046395. 20 test Kit In Vitro Diagnostic test for Herpes Simplex Virus 2

    Recall: Z-1971-2010 · Initiated April 14, 2010

    Recall

    Recall Number
    Z-1971-2010
    Event Number
    55316
    Firm
    Biokit U.S.A. Inc.
    FEI Number
    1000513333
    Product Code
    LGC
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 14, 2010
    Posted
    July 8, 2010
    Terminated
    January 26, 2012
    Address
    180 Hartwell Rd, Bedford, MA, 01730-2443

    Description

    Sure-Vue HSV-2 Rapid Test, Catalogue No: 23-046395. 20 test Kit In Vitro Diagnostic test for Herpes Simplex Virus 2

    Reason

    Negative serum was giving a positive result Herpes Simplex Type 2 (HSV-2). It is possible that misdiagnosis (i.e., positive) could be made.

    Action

    Biokit USA notified US Customers by fax on 2/18/10 of the reason for the kit recall and requested to discard any remaining units. Accounts were advised to retest patients or review test results. Questions are directed to the firm at 800-926-3353.

    Distribution

    US (CA, FL, GA, IN, KY, MA, NY, VA) and UK

    Quantity

    8 kits