BEUDAMED
    FDA Enforcement Class III Terminated

    ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems.

    Recall: Z-0173-2014 · Reported November 13, 2013

    Enforcement

    Recall Number
    Z-0173-2014
    Event ID
    66132
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 13, 2013
    Initiation Date
    August 16, 2013
    Classification Date
    November 6, 2013
    Termination Date
    February 13, 2014
    Address
    333 Coney St, N/A, East Walpole, MA, 02032-1516, United States

    Description

    ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems.

    Reason

    PTH Calibrator packaged with only high calibrator.

    Code Info

    Kit Lot: 14136A16 04 Mar 2014

    Distribution

    Nationwide Distribution including MD, PA, and CT.

    Quantity

    595 kits total (5 kits with packaging error)