Events

Device Recall Siemens Total Iron Binding Capacity (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
    64063
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0933-2013
  • 사례 시작날짜
    2012-12-20
  • 사례 출판 날짜
    2013-03-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-08-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115310
  • 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
    The analytical sensitivity claim of 6 ug/dl (1.1 umol/l) in the instructions for use (ifu) is no longer valid. siemens is conducting a voluntary corrective action for dimension total iron binding capacity (ibct) to modify the analytical sensitivity claim to 36 ug/dl (6.44 umol/l).
  • 조치
    Siemens Healthcare sent a "Urgent Medical Device Correction" letter dated Dec 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were notified that theanalytical sensitivity of 6 ug/dL (1.1 umol/L) in the Dimension(R) IBCT FLex(R) Reagent Cartridge instructions for us (IFU) is no longer valid. Please make adjustments to middle wave products or Laboratory Information Systems ( LIS ) as appropriate for your Laboratory. Please complete the attached form and fax it to (302) 631-8467, to indicate you have received this information. If you have any questions please contact your Siemens Technical Solutions Center or your local Siemens technicial support representative at (302) 631-6311.

Device

Device Recall Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge
  • 모델명 / 제조번호(시리얼번호)
    Siemens Material Number (SMN) 10444944, Catalog number DF84 -- lot numbers BA3016, EXP 2013-01-16; EC3045, EXP 2013-02-14; EA3073, EXP 2013-03-14; DC3102, EXP 2013-04-12; FC3122, EXP 2013-05-02; EA3157, EXP 2013-06-06; BB3184, EXP 2013-07-03; EC3219, EXP 2013-08-07; EC3220, EXP 2013-08-08; GA3248, 2013-09-05; and FB3290, EXP 2013-10-17
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. || An in vitro diagnostic test intended to quantitatively measure Total Iron Binding Capacity in human serum.
  • 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