BEUDAMED
    FDA Recall Terminated

    Product is packaged in a box and is labeled: Syphilis TREP-CHEK No. 720-100-10, 960 test, For in Vitro Diagnostic Use Lot 71303 Exp. Jun 04 Diamedix, A subsidiary of IVAX Diagnostics, Inc. MIAMI, FL 33127

    Recall: Z-0513-04 · Initiated December 9, 2003

    Recall

    Recall Number
    Z-0513-04
    Event Number
    28083
    Firm
    Diamedix Corporation
    FEI Number
    1044713
    Product Code
    LIP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 9, 2003
    Posted
    July 20, 2004
    Terminated
    November 20, 2008
    Address
    2140 N Miami Ave, Miami, FL, 33127-4916

    Description

    Product is packaged in a box and is labeled: Syphilis TREP-CHEK No. 720-100-10, 960 test, For in Vitro Diagnostic Use Lot 71303 Exp. Jun 04 Diamedix, A subsidiary of IVAX Diagnostics, Inc. MIAMI, FL 33127

    Reason

    The test kit may have the potential to give erroneous results in that it may give higher frequency of equivocal/low positive results.

    Action

    A recall notification letter was mailed to each consignee/user account on 12/9/2003 telling them that the recalled lot may give a higher frequency of equivocal/weak positive results. It requests them to discontinue use and to return the product to them. Also they are asked to sign and date the bottom of the recall letter and fax it back to the recalling firm.

    Distribution

    Product was distributed to three hospitals/clinics in AZ, CA and TX.

    Quantity

    8