Events

Device Recall ADVIA Centaur TniUltra" Assay 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
    74036
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2041-2016
  • 사례 시작날짜
    2016-05-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-02-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146020
  • 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
    Immunoassay method, troponin subunit - Product Code MMI
  • 원인
    Exhibits a greater than 10% change in results in samples with biotin levels up to 10 ng/ml (41 nmol/l). instructions for use (ifu) states that specimens that have up to 10 ng/ml (41 nmol/l) of biotin.
  • 조치
    Siemens Healthcare sent an Urgent Medical Device Correction letter dated May 2, 2016, The letter identified the product, the problem and the action to be taken by the customer. Customers were instructed to continue use of the affected product, review the letter with their doctor, complete and return the Field Correction Effectiveness Check attached to the letter. If customers received any complaints of illness or adverse events associated wit the affected product they should immediately contact their local Siemens Customer Care Center or their local Siemens technical support representative. Customers with questions should contact their Siemens Customer Care Center or their local Siemens technical support representative. For questions regarding this recall call 508-668-5000.

Device

Device Recall ADVIA Centaur TniUltra" Assay
  • 모델명 / 제조번호(시리얼번호)
    All in date lots
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (Nationwide) and Internationally to Albania Austria Belgium Bulgaria Burkina Faso Canada Croatia Cyprus Czech Republic Denmark Egypt Estonia Finland France French Polynesia Georgia Germany Great Britain Greece Guadeloupe Hungary Iceland Italy Kazakhstan Latvia Lithuania Luxembourg Macedonia Malta Martinique Netherlands Norway Poland Portugal Romania Russian Federation Serbia Slovakia Slovenia Spain Sweden Switzerland Tunisia Turkey United Arab Emirates and Uzbekistan.
  • 제품 설명
    Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative determination of cardiac troponin For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT/ADVIA Centaur CP systems || Cat No. 02789602/SMN 1031 7708 (100 test) || Cat No. 02790309/SMN 10317709 (500 test)
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc

Manufacturer

Siemens Healthcare Diagnostics, Inc
  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA