Events

Device Recall Dimension Vista(R) MG Flex(R) Reagent Cartridge 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Healthcare Diagnostics, Inc. 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
    61465
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1433-2012
  • 사례 시작날짜
    2012-02-17
  • 사례 출판 날짜
    2012-04-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-03-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108165
  • 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
    Photometric method, magnesium - Product Code JGJ
  • 원인
    Firm has confirmed a negative shift of approximately 0.2mg/dl [0.08 mmol/l] in patient and qc samples when using vista magnesium.
  • 조치
    Siemens sent an Urgent Field Safety Notification letter dated February 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter explained the correction needed and instructed customers to forward the letter to anyone they may have distributed the affected product. For questions or concerns call 800-441--9250. For questions regarding this recall call 301-631-6299.

Device

Device Recall Dimension Vista(R) MG Flex(R) Reagent Cartridge
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers 11263AC, 11286AB, 11306BA, 11332AB, 11332AC and 12010AB.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including Puerto Rico and within the US to Washington, DC and the following States: AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico.
  • 제품 설명
    Dimension Vista(R) MG Flex(R) Reagent Cartridge || The Dimension Vista(R) MG method is an in vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista(R) System
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA