BEUDAMED
    FDA Enforcement Class II Terminated

    Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporation, Fremont, CA MAS Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Includes Bilirubin with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

    Recall: Z-1563-2013 · Reported July 3, 2013

    Enforcement

    Recall Number
    Z-1563-2013
    Event ID
    65187
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Microgenics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 3, 2013
    Initiation Date
    May 13, 2013
    Classification Date
    June 21, 2013
    Termination Date
    August 27, 2013
    Address
    44660 Osgood Rd, Fremont, CA, 94539-6410, United States

    Description

    Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporation, Fremont, CA MAS Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Includes Bilirubin with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

    Reason

    It has been confirmed from in-house testing that Direct Bilirubin (DBIL), and Total Bilirubin (TBIL) claimed in Thermo Scientific MAS Bilirubin Systems are displaying reduced stability.

    Code Info

    Catalog Number: 10014432; Lot Numbers: 1MQ310, Expiration Date: 31 Dec 2013, 2CQ310, Expiration Date: 31 Mar 2014, 2KQ310, Expiration Date: 31 Oct 2014

    Distribution

    Nationwide Distribution: US including the states of WI, UT, FL NY, PA, IL, CO, AZ and NJ.

    Quantity

    188