BEUDAMED
    FDA Recall Terminated

    MicroScan Rapid Pos Inoculum Broth, Catalog #: B1015-14; Manufactured and distributed by: Dade Behring Inc. 2040 Enterprise Blvd. West Sacramento, CA 95691

    Recall: Z-0668-05 · Initiated February 7, 2005

    Recall

    Recall Number
    Z-0668-05
    Event Number
    31125
    Firm
    Dade Behring
    FEI Number
    2919016
    Product Code
    LON
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 7, 2005
    Posted
    April 6, 2005
    Terminated
    July 5, 2005
    Address
    2040 Enterprise Blvd, West Sacramento, CA, 95691-3427

    Description

    MicroScan Rapid Pos Inoculum Broth, Catalog #: B1015-14; Manufactured and distributed by: Dade Behring Inc. 2040 Enterprise Blvd. West Sacramento, CA 95691

    Reason

    There is a potential for reporting of false susceptible anti-microbic results that could result in inappropriate and/or less effective therapy.

    Action

    The customer notifications were sent to U.S. customers on January 27, 2005 via FedEx. International customers are to be notified by Dade Behring affiliates in the affected countries by February 10, 2005. Follow up will be made via phone call.

    Distribution

    71 consignees including customers in U.S., Puerto Rico and distributors. Number of international customers to be determined at completion of effectiveness check.

    Quantity

    324 boxes