Device Recall CoaguChek XS Plus System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Roche Diagnostics Operations, 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
    65246
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1583-2013
  • 사례 시작날짜
    2013-05-16
  • 사례 출판 날짜
    2013-06-24
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2014-04-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Test, time, prothrombin - Product Code GJS
  • 원인
    Roche has confirmed the potential for an undetected elevated inr test result with the coaguchek xs, coaguchek xs plus, and coaguchek xs pro meters. in rare cases, instead of a value, an error 6 message is displayed.
  • 조치
    Rochet sent an Urgent Medical Device Correction letter dated May 16, 2013, via UPS Ground to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were issued the following instructions: If you are using Warfarin therapy in combination with antibiotics and/or chemotherapy drugs, which could potentially lead to an extremely high test result (> 10 INR), you may in rare cases receive repeated ERROR 6 messages instead of a test result. If the ERROR 6 message is displayed repeatedly on your CoaguChek XS meter, immediately contact your treating physician. The CoaguChek XS PT Test Strip package insert; the online version of the CoaguChek XS PST system users manual; and the CoaguChek XS systems are being updated to provide additional ERROR 6 message information and actions. Updated versions will be available on the www.poc.roche.com website by the end of June 2013. Health Care Professionals are instructed to use an alternative method to determine INR results if an ERROR 6 message is displayed repeatedly on the CoaguChek XS, CoaguChek XS Plus, or CoaguChek XS Pro meters for the same patient. Self testing patients are instructed to contact their Health Care provider immendiately if the ERROR 6 message is displayed repeatedly on the CoaguChek XS. Please contact your Roche Account Manager or Roche Diagnostics Point of Care Technical Service, 24 hours a day, seven days a week at 1-800-428-4674 if you have questions about the information contained in this UMDC. For questions regarding this recall call 317-521-3711.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model/Catalog/Part Number: 05021537001
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    CoaguChek XS Plus System || The CoaguChek XS Plus system for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • 제조사 모회사 (2017)
  • Source
    USFDA