Device Recall Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems

  • Modèle / numéro de série
    Catalog Number: 10014432;  Lot Numbers:  1MQ310, Expiration Date: 31 Dec 2013, 2CQ310, Expiration Date: 31 Mar 2014, 2KQ310, Expiration Date: 31 Oct 2014
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution: US including the states of WI, UT, FL NY, PA, IL, CO, AZ and NJ.
  • Description du dispositif
    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.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Microgenics Corporation, 44660 Osgood Rd, Fremont CA 94539-6410
  • Société-mère du fabricant (2017)
  • Source
    USFDA