BEUDAMED
    FDA Enforcement Class II Terminated

    ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 03439230 (2 pack)

    Recall: Z-0128-2015 · Reported November 5, 2014

    Enforcement

    Recall Number
    Z-0128-2015
    Event ID
    69449
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 5, 2014
    Initiation Date
    October 9, 2012
    Classification Date
    October 24, 2014
    Termination Date
    June 18, 2015
    Address
    333 Coney St, N/A, East Walpole, MA, 02032-1516, United States

    Description

    ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 03439230 (2 pack)

    Reason

    Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system

    Code Info

    Lot numbers: 82052A22 Exp Date 01/19/2013 82335A22 82909A22 85268A22 86701B22 88921B22 89956B22 90925B22 91336B22 95231A23 Exp. Date: 01/16/2013 95553A23

    Distribution

    Worldwide Distribution - Nationwide Distribution and the countries of Argentina, Australia, Brazil, Canada, China, Columbia, Egypt, Hong Kong, India, Israel, Indoenesia, India, Japan, Korea, Mexico, Malaysia, Philippines, Saudi Arabia, Singapore, Taipei, Uruguay, Venezuela, Viet Nam and South Africa.

    Quantity

    8263 kits