Events

Device Recall Dimension IBCT 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
    54460
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2385-2010
  • 사례 시작날짜
    2009-12-16
  • 사례 출판 날짜
    2010-09-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-10-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88527
  • 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
    Ferrozine (colorimetric) iron binding capacity - Product Code JMO
  • 원인
    Test produces falsely elevated ibct results and abnormal reaction test report messages on heparinized plasma samples.
  • 조치
    Siemens issued an "Urgent Field Safety Notice" letter dated December 2009 to users identifying the issue and affected product. Customers were instructed not to use heparinized plasma samples for IBCT testing. IBCT Instructions for Use (IFU) has been updated to reflect that heparinized plasma is no longer an acceptable sample type. Beginning with lot ED0341, the new IFU will be packaged in the carton with the IBCT Flex¿ reagent cartridges. Consignees were requested to forward the notification letter to anyone to whom the product was distributed. The Siemens Technical Solutions Center can be contacted at 800-441-9250.

Device

Device Recall Dimension IBCT Flex Reagent Cartridge
  • 모델명 / 제조번호(시리얼번호)
    Catalog number df84
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA (all states) and the countries of Canada, Switzerland, New Zealand, Australia, Japan, and South Korea.
  • 제품 설명
    Dimension IBCT Flex Reagent Cartridge. The total (IBCT) method used on the Dimension system is an in vitro diagnostic test intended to quantitatively measure Total Iron Binding capacity in human serum and plasma.
  • 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