Events

Device Recall Enzymatic Creatinine (ECREA) Flex(R) reagent cartridges 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
    58379
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2154-2011
  • 사례 시작날짜
    2010-06-10
  • 사례 출판 날짜
    2011-05-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-12-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99240
  • 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
    Enzymatic, method, creatinine - Product Code JFY
  • 원인
    Results may be falsely depressed up to 0.4 mg/dl or falsely elevated up to 0.6 mg/dl across the assay range.
  • 조치
    Siemens sent an Urgent Field Safety Notice letter dated June 2010 to all Dimension Vista(R) ECREA customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to: Discontinue use of ECREA method and transition to the Dimension(R) Jaffe creatinine (CREA) method. To notify anyone to whom they may have distributed the product. Complete and return the Effectiveness Check Questionnaire attached to the letter by fax to (302) 631-8467. For questions regarding this recall call (302) 631-6299.

Device

Device Recall Enzymatic Creatinine (ECREA) Flex(R) reagent cartridges
  • 모델명 / 제조번호(시리얼번호)
    Catalog number K1270 - lot numbers 09224AA, 09286AA, 09350AC, 10011AF, 10047AA, 10089AC, 10089AD, 10131AC and 10131AD.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution - including AL, AZ, CA, CO, DE, FL, GA, ID, IL, IA, MD, MA, MI, MT, NH, NJ, NY, NC, OH, OR, PA, SC, TX, VA, WA, and WI.
  • 제품 설명
    Enzymatic Creatinine (ECREA) Flex(R) reagent cartridges, K1270 for the Dimension Vista(R) 500 System || The ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista(R) System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for other urine analytes.
  • 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