BEUDAMED
    FDA Recall Terminated

    VeriCal Calibrator Set

    Recall: Z-0032-06 · Initiated August 19, 2005

    Recall

    Recall Number
    Z-0032-06
    Event Number
    33440
    Firm
    BIOMERIEUX, INC.
    FEI Number
    3002769706
    Product Code
    JPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 19, 2005
    Posted
    October 22, 2005
    Terminated
    October 16, 2006
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    Description

    VeriCal Calibrator Set

    Reason

    The product is being recalled due to mis-assignment of ISI values associated with VeriCal use.

    Action

    Consignees were notified on/about 08/31/2005.

    Distribution

    Nationwide

    Quantity

    2334 kits