Events

Device Recall Dimension Tacrolimus Flex 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
    56145
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2407-2010
  • 사례 시작날짜
    2010-06-15
  • 사례 출판 날짜
    2010-09-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-12-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92742
  • 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
    Low patient sample recovery results in all affected lots, with possibility of inappropriate increase in tacrolimus dosage based on false low result.
  • 조치
    Siemens issued an "Urgent Field Safety Notice" dated June, 2010 to all affected customers. Customers were requested to immediately discontinue use and discard any remaining inventory of the TACR Flex reagent lots DC0306, CA0320, DA0334 and GA0348. The letter contains the following instructions: 1) Immediately discontinue use of the affected lots; 2) Discard all remaining inventory of the affected lots; 3) Contact Siemens Healthcare Diagnostics Technical Solutions Center for replacement product; 4) Complete and return the Field Correction Effectiveness Check by fax to 302 631-8467; 4) Siemens is recommending that the content of the letter should be discussed with the laboratory director. If unexpectedly low results are obtained on a patient sample, caution should be exercised before decisions regarding therapeutic dosage adjustments are made. As stated in the package insert, "Confirmation of unexpected or atypical results by an alternative methodology is recommended prior to any adjustments in tacrolimus dosage. Also individual tacrolimus values cannot be used as the sole indicator for making changes in the treatment regimen. Each patient should be thoroughly evaluated clinically before treatment adjustments are made." Siemens Technical Solutions Center may be contacted at 800-441-9250

Device

Device Recall Dimension Tacrolimus Flex Reagent Cartridge
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: DC0306 (exp 11/2/10), CA0320 (exp 11/16/10), DA0334 (exp 11/30/10), GA0348 (exp 12/14/10)
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution to USA states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, KS, LA, MI, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA and WI, and countries of Austria, Belgium, Canary Islands, Egypt, France, Germany, Great Britain, Hungary, Italy, The Netherlands, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, Sweden, United Arab Emirates, Argentina, Brazil, Canada, Columbia, El Salvador, Venezuela, Australia, Hong Kong, India, Japan, Malaysia, New Zealand, South Korea, Singapore, Taiwan and China.
  • 제품 설명
    Dimension Tacrolimus Flex Reagent Cartridge, manufactured by Siemens Healthcare Diagnostics Inc., Newark, Delaware.
  • 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