Events

Device Recall Dimension Vista(R) VANC 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
    62609
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2175-2012
  • 사례 시작날짜
    2012-07-17
  • 사례 출판 날짜
    2012-08-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-01-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111137
  • 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
    Radioimmunoassay, vancomycin - Product Code LEH
  • 원인
    Siemens has received complaints of customers experiencing slopes >1.05 when calibrating flex(r) reagent cartridge lot 12095ad. this results in a slope failure and prevents the vanc assay from being run on the dimension vista(r) system.
  • 조치
    The firm initiated their recall of this product on July 17, 2012 by sending an Urgent Field Safety Notification via FedEx next day delivery to all consignees. The Notice informed consignees of the high calibration slopes with the affected device. Affected consignees were requested to immediately discontinue use and discard any remaining Dimension Vista(R) VANC Flex(R) reagent cartridges, lot 12095AD. Affected customers were provided with replacement cartridges. Customers were to also complete the attached form and fax it back to the number provided. The notification letter should be forwarded to anyone, whom customers may have further distributed the affected lot. Questions and concerns should be directed to Siemens Technical Solutions Center at 800-441-9250.

Device

Device Recall Dimension Vista(R) VANC Flex(R) Reagent Cartridge
  • 모델명 / 제조번호(시리얼번호)
    lot 12095AD, exp 2013-04-04
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, including Washington, DC and the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WV, and the countries of Canada, New Zealand, Germany, and Puerto Rico.
  • 제품 설명
    Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). || For the quantitative measurement of vancomycin in human serum and plasma on the Dimension Vista 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