Events

Dimension(R) TACR Flex(R) reagent cartridge (DF107) 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
    65051
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0517-2014
  • 사례 시작날짜
    2013-04-25
  • 사례 출판 날짜
    2013-12-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-11-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117800
  • 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
    Enzyme immunoassay, tracrolimus - Product Code MLM
  • 원인
    Siemens has confirmed that the tacr method may demonstrate reduced on-board stability which may result in imprecise and inaccurate qc and patient results.
  • 조치
    Siemens sent an Urgent Medical Device Correction letter dated April 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. A recall notification letter was sent to consignees in April 2013. Customers using the affected product should load Flex reagent cartridges on board immediately prior to use and remove the Flex after 8 hours. Do not load more Flexes than the lab will use in 8 hours and do not pre-hydrate TACR Flexes. Customers were asked to complete the attached Effectiveness Check form and fax it to the Siemens Technical Solutions Center at 302-631-8467. Customers were asked to forward the communication to anyone to whom may have distributed the product. Customers with questions were instructed to contact the Siemens Technical Solutions Center or their local Siemens technial support representative. For questions regarding this recall call 800-441-9250.

Device

Dimension(R) TACR Flex(R) reagent cartridge (DF107)
  • 모델명 / 제조번호(시리얼번호)
    Siemens Material Number 10444938, lot numbers GB3099, GA3120, DB3141, GB3162, GB3176, FA3197, FA3267 and FB3267.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including AK, AL, AR, AZ, CA, DC, FL, GA, IA, IL, LA, MD, MI, MO, MS, NC, NH, NJ, NM, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, and WI.
  • 제품 설명
    Dimension(R) TACR Flex(R) reagent cartridge (DF107) || The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension(R) clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of Tacrolimus therapy in kidney and liver transplant patients
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA