Events

Device Recall MEDITECH BiDirectional LAB Analyzer Interface 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medical Information Technology, 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
    65158
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1365-2013
  • 사례 시작날짜
    2013-05-07
  • 사례 출판 날짜
    2013-05-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-10-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118048
  • 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
    Medical device data system - Product Code OUG
  • 원인
    Incorrect transmission of laboratory results.
  • 조치
    Beginning on May 7, 2013, MEDITECH distributed a notification to MAGIC and Client Server customers who have the MEDITECH Bi-Directional Interactive Communication Analyzer Interface in use with Vitros 3600, 4600, or 5600 Analyzer in TEST and/or LIVE. This notification was made via remailed task updates that can be printed by the customer. Task updates sent via e-mail are immediately transmitted to the customer. This notification informs customers of the potential patient safety issue that could result in reporting inaccurate qualitative results. Customers will receive a corrective change, in which the previous test's results will no longer be associated with the test not performed. Until customers receive the corrective change, they are instructed to monitor all No Result values from their analyzer and confirm that the result in MEDITECH matches. For further questions please call 781-821-3000, ext. 5742.

Device

Device Recall MEDITECH BiDirectional LAB Analyzer Interface
  • 모델명 / 제조번호(시리얼번호)
    Magic Releases 5.41, 5.52. 5.53, 5.62, 5.63, 5.64 and Client Server Releases 5.64, 5.65, 6.05, 6.06, 6.07
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA, including Puerto Rico and the country of Canada.
  • 제품 설명
    MEDITECH Bi-Directional interactive Communication Analyzer Interface; || Integrates with MEDITECH's Laboratory Information System (LIS) with Other Vendor systems to manage the transfer of patient results and demographic information.
  • Manufacturer
    Medical Information Technology, Inc.

Manufacturer

Medical Information Technology, Inc.