BEUDAMED
    FDA Recall Terminated

    BBL" OXACILLIN SCREEN AGAR, catalog #221952, box of 10 plates. Oxacillin Screen Agar (originally named MRSA Screen Agar) was developed for the detection of methicillin-resistant Staphylococcus aureus (MRSA). These strains are resistant to penicillinase-resistant penicillins (PRPs), such as methicillin, oxacillin and nafcillin. Since the method to detect MRSA uses the same inoculum as the Bauer-Kirby antimicrobial disc susceptibility test procedure, the oxacillin screen test may be conveniently performed on isolates at the same time as routine susceptibility testing.

    Recall: Z-2608-2011 · Initiated April 20, 2011

    Recall

    Recall Number
    Z-2608-2011
    Event Number
    58906
    Firm
    Becton Dickinson & Co. BD Diagnostic Systems
    FEI Number
    1119779
    Product Code
    JTZ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 20, 2011
    Posted
    June 21, 2011
    Terminated
    August 15, 2011
    Address
    7 Loveton Circle, Sparks, MD, 21152-0999

    Description

    BBL" OXACILLIN SCREEN AGAR, catalog #221952, box of 10 plates. Oxacillin Screen Agar (originally named MRSA Screen Agar) was developed for the detection of methicillin-resistant Staphylococcus aureus (MRSA). These strains are resistant to penicillinase-resistant penicillins (PRPs), such as methicillin, oxacillin and nafcillin. Since the method to detect MRSA uses the same inoculum as the Bauer-Kirby antimicrobial disc susceptibility test procedure, the oxacillin screen test may be conveniently performed on isolates at the same time as routine susceptibility testing.

    Reason

    Oxacillin Screen Agar may not have been produced according to specification and could result in false antibiotic susceptibility test results in patient specimens.

    Action

    BD Diagnostic Systems sent an "URGENT PRODUCT RECALL" letter dated April 2011 to all affected customers. The letter identifies the product, problem and actions to be taken by the customers. The letter instructed customers to discontinue use of the affected lot number and discard any remaining packages. Customers were requested to complete and return an attached response form via fax at 410-316-4258. The letter states that all discarded product will be replaced. Questions concerning the recall process were directed to BD Customer Service Department at 1-800-675-0908.

    Distribution

    Worldwide Distribution--USA (nationwide) and the countries of Canada, Columbia, Jamaica, South Korea, and Taiwan.

    Quantity

    5440 plates