BEUDAMED
    FDA Recall Terminated

    BD ProbeTec ET Urine Processing Kit, 4x25, catalog 440454, packaged in a carton containing 4 storage bags identified as BD ProbeTec ET Urine Processing Pouches, 25 pouches/bag. Carton and bags labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152***

    Recall: Z-0455-05 · Initiated January 10, 2005

    Recall

    Recall Number
    Z-0455-05
    Event Number
    30844
    Firm
    Becton Dickinson & Co.
    FEI Number
    1119779
    Product Code
    LSL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 10, 2005
    Posted
    February 3, 2005
    Terminated
    April 19, 2005
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212

    Description

    BD ProbeTec ET Urine Processing Kit, 4x25, catalog 440454, packaged in a carton containing 4 storage bags identified as BD ProbeTec ET Urine Processing Pouches, 25 pouches/bag. Carton and bags labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152***

    Reason

    An in-vitro diagnostic kit reagent may cause false negative clinical results in patients tested for sexually transmitted infections.

    Action

    BD notified consignees by phone on 01/10/05 and advised that users transporting patient urine samples may experience increased indeterminate results or false negative results when testing the samples on the BD ProbeTec ET CT/GC Amplified DNA Assay. Subsequest to the phone notification, kit users identified as utilizing the Urine Processing Pouches were further notified by a letter. The letter describes 4 criteria contributing to the risk associated with false negative and indeterminate results. The letter advised users to discontinue use of the kits and discard for replacement. BD further advised in the notification that if the user is not utilizing the Amplification Control (AC), the firm recommends that they evaluate if urine specimens were transported and/or stored at refrigerated temperatures in the kit''s urine pouches. If specimens were transported and/or stored under the noted criteria, BD recommends that users should notify physicians who received reports of negative patient results and indicate that there is a possibility that these results were incorrect. BD plans to provide a 'Dear Physician' letter that would facilitate that notification upon request of the users.

    Distribution

    Product was distributed to direct accounts in the US and to affiliated distributors internationally.

    Quantity

    2175 kits