BEUDAMED
    FDA Recall Terminated

    BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du Parc-Technologique, Quebec, Canada G1P 4S5***BD Max Group B Streptococcus (GBS) Assay is an in vitro diagnostic (IVD) test for detection of GBS DNA in Lim Broth cultures. The BD MAX" PCR Cartridge is a consumable required for the BD MAX" System.

    Recall: Z-0976-2013 · Initiated December 11, 2012

    Recall

    Recall Number
    Z-0976-2013
    Event Number
    64310
    Firm
    Becton Dickinson & Co. BD Diagnostic Systems
    FEI Number
    1119779
    Product Code
    NJR
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 11, 2012
    Posted
    March 22, 2013
    Terminated
    July 22, 2013
    Address
    7 Loveton Circle, Sparks, MD, 21152-0999

    Description

    BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du Parc-Technologique, Quebec, Canada G1P 4S5***BD Max Group B Streptococcus (GBS) Assay is an in vitro diagnostic (IVD) test for detection of GBS DNA in Lim Broth cultures. The BD MAX" PCR Cartridge is a consumable required for the BD MAX" System.

    Reason

    Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs.

    Action

    BD Diagnostic Systems issued an Urgent Product Recall letter via UPS delivery on December 11, 2012. The letter identified the product, the problems, and the action to be taken by the customer. Customers were instructed to take the following actions: Discontinue and discard any affected product. BD would send replacements for the discarded material. Complete the attached form whether or not they have any inventory remaining so that the firm may acknowledge their receipt of the notification. Fax the form to: Attention: Regulatory Compliance, Fax: 410-316-4258 or Email to [email protected].. If further assistance is needed regarding replacements, please contact BD Customer Service Department at 1-800-675-0908. For all other inquiries, contact BD Technical Services Department at 1-800-638-8663. The BD site in Belgium was notified via email. For questions regarding this recall call 410-316-4054.

    Distribution

    Worldwide Distribution - USA including CA, FL, IN, IL, KS, NY, OH, OR, PA, TX, and WI and the country of Belgium

    Quantity

    27 boxes/648 cartridges