Events

Siemens Dimension Phenytoin 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
    69372
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0148-2015
  • 사례 출판 날짜
    2014-10-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-08-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130331
  • 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, diphenylhydantoin - Product Code DIP
  • 원인
    Internal testing has confirmed a low absorbance range between the levels 1 and 5 calibrators with this lot resulting in the potential for a positive or negative bias and imprecision across the ptn assay range.
  • 조치
    Siemens sent an Urgent Medical Device Recall Notification dated September 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed as follows: " Discontinue use and discard any remaining inventory of PTN lot FA5154, and complete the attached form indicating your replacement product needs in the attached Field Correction Effectiveness Form. " Siemens will replace any unused inventory of the affected lot at no charge. We apologize for the inconvenience this situation may have cause. If you have any questions, please contact Siemens Customer Care Center - Technical Solutions at (800) 441-9250, or your local Siemens technical support representative.

Device

Siemens Dimension Phenytoin Flex Reagent Cartridge
  • 모델명 / 제조번호(시리얼번호)
    lot FA5154, exp. 2015-06-03
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including Puerto Rico., and the countries of Australia, Brazil, Bahamas, Canada, Chile, India, Japan and Uruguay
  • 제품 설명
    siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge || The PTN method used on the Dimension¿ clinical chemistry system is an in vitro diagnostic test intended to measure phenytoin (dilantin, diphenylhydantoin), an anti-epileptic drug, in human serum and plasma. PTN test results are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to ensure appropriate therapy.
  • 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