BEUDAMED
    FDA Recall Terminated

    Dade Behring brand MicroScan Prompt Inoculation System-D; Catalog # B1026-10D;

    Recall: Z-0247-2007 · Initiated September 27, 2006

    Recall

    Recall Number
    Z-0247-2007
    Event Number
    36600
    Firm
    Dade Behring, Inc.
    FEI Number
    2919016
    Product Code
    LIE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 27, 2006
    Posted
    December 5, 2006
    Terminated
    December 28, 2006
    Address
    2040 Enterprise Blvd, West Sacramento, CA, 95691-3427

    Description

    Dade Behring brand MicroScan Prompt Inoculation System-D; Catalog # B1026-10D;

    Reason

    Product does not meet performance specifications through its standardized inocula for MicroScan Dried Gram-Negative and Gram-Positive Overnight panel testing.

    Action

    On 9/27/06, the firm initiated the recall and its notification was via phone calls and letters (FedEx''ed) explaining the reason for the recall and requesting the product be discarded.

    Distribution

    Worldwide, including USA, China, and Germany.

    Quantity

    828 units