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

  • 모델명 / 제조번호(시리얼번호)
    Catalog Number: 10014432;  Lot Numbers:  1MQ310, Expiration Date: 31 Dec 2013, 2CQ310, Expiration Date: 31 Mar 2014, 2KQ310, Expiration Date: 31 Oct 2014
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution: US including the states of WI, UT, FL NY, PA, IL, CO, AZ and NJ.
  • 제품 설명
    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

제조사

  • 제조사 주소
    Microgenics Corporation, 44660 Osgood Rd, Fremont CA 94539-6410
  • 제조사 모회사 (2017)
  • Source
    USFDA