Events

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

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Microgenics Corporation 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    65187
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1563-2013
  • 사례 시작날짜
    2013-05-13
  • 사례 출판 날짜
    2013-06-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-08-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118166
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Single (specified) analyte controls (assayed and unassayed) - Product Code JJX
  • 원인
    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.
  • 조치
    ThermoFisher Scientific sent a Product Recall Notification letter dated May 13, 2013, by Certified US mail to all affected customer. The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed 1. Determine if you are using or have inventory of the recalled product. 2. Discontinue use of the product immediately. 3. Evaluate quality controls. They may vary among laboratories and should be evaluated according to laboratory procedures. 4. Retain a copy of the letter for laboratory records. 5. If any of the affected lots of MAS Bilirubin had been forwarded to another laboratory, please provide a copy of the recall letter to them. 6. Complete and return the response form within 5 days. Letters also provide an alternative product - MAS Bilirubin part number BC103. Questions or concerns may be directed to Technical Services at 1-800-232-3342 or 510-979-5417.

Device

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
    Clinical Chemistry and Clinical Toxicology Devices
  • 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
    Microgenics Corporation

Manufacturer

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