Events

Dimension Enzymatic Creatinine Flex reagent cartridge 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Dade Behring, 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
    50075
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0485-2009
  • 사례 출판 날짜
    2008-12-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-03-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74652
  • 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
    Creatinine enzymatic method - Product Code JFY
  • 원인
    Reagent may exhibit unflagged inaccurate patient sample results.
  • 조치
    The recalling firm telephoned all customers on 9/29/08 to inform them of the problem. Customers were issued a letter dated 9/29/08 (and a response form) with instructions. Customers were instructed to complete the response form and fax (302-631-7242) it to Siemens Healthcare Diagnostics. For questions or additional information, contact the Siemens Technical Solutions Center at 800-441-9250.

Device

Dimension Enzymatic Creatinine Flex reagent cartridge
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: CB9107, DB9093, DB9100, EB9077, EC9077, FC9062, GA9043, GD9069, and GD9087.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Dimension Enzymatic Creatinine Flex reagent cartridge, DF270. || The ECRE method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the clinical chemistry 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
    Dade Behring, Inc.

Manufacturer

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