BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSCAN RAPID POST INOCULUM BROTH

    MDR report key: 627524 · Received August 13, 2005

    Report

    Report Number
    2919016-2005-00012
    Event Type
    Malfunction
    Date Received
    August 13, 2005
    Date of Event
    December 22, 2004
    Report Date
    December 22, 2004
    Manufacturer
    DADE BEHRING, INC.
    Product Code
    JSO
    Removal / Correction Number
    Z-0668-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    QC S. AUREUS ATCC 29213 AND CLINICAL ISOLATES VERSUS OXACILLIN WERE OUT HIGH (RESISTANT) WHEN USED WITH RAPID POSITIVE MIC LOT #2005-03-14. THIS ISSUE HAS BEEN ASSOCIATED WITH A DADE BEHRING CONDUCTED RECALL FOR MICROSCAN RAPID POS BROTH INOCOLUM BROTH, LOTS 050905A-1, 051605A-1, 051605A-1, 051705A-1, 052305A-1 AND 052805B-1 THAT TOOK PLACE IN 01/05.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSCAN RAPID POST INOCULUM BROTH INOCULUM BROTH JSO DADE BEHRING, INC. NA MULTIPLE

    Patients

    Seq Age Sex Outcome Treatment
    1 *