Events

Remisol Advance Software Versions 1.6-1.9, Architect Driver 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Beckman Coulter Australia Pty Ltd 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
    RC-2017-RN-01404-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-11-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01404-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Beckman coulter has identified a potential issue due to a software nonconformity which could occur after a default service setting (“nocondition”) is manually changed from off to on, potentially causing results outside of analytical range to be erroneously displayed. please note that the “nocondition” setting is not customer configurable through any instructions, but is reserved for field service configuration. if both conditions occur at the same time, i.E. the changed setting and a result outside of analytical range, an incorrect result could potentially be reported to the physician.
  • 조치
    Beckman Coutler is advising users to check device settings as directed in the letter supplied to customers. If the setting is correct there is no further action required. If the setting is NOT correct, users should contact their local Beckman Coulter representative immediately, and either: (1) discontinue use of Remisol with the Architect instrument; or (2) monitor results sent from the Architect instrument to Remisol to ensure Remisol does not receive results outside the dynamic range from the Architect instrument.

Device

Remisol Advance Software Versions 1.6-1.9, Architect Driver
  • 모델명 / 제조번호(시리얼번호)
    Remisol Advance Software Versions 1.6-1.9, Architect DriverARTG Number - 296020
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd