Events

BenchMark ULTRA with software versions VSS 11.9 or higher, and DISCOVERY ULTRA clinical chemistry analysers (used for detecting and preparing tissue morphology and components). An in vitro diagnostic medical device (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Roche Diagnostics Australia Pty Limited 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-2015-RN-01032-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-10-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01032-1
  • 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
    Internal investigations by roche diagnostics have uncovered the potential for incorrect slide staining (ihc/ish) to occur on the benchmark ultra instrument or discovery ultra instrument running ventana system software (vss) 11.9 or higher, due to the possibility of a duplicate keycode error. the embedded software for the barcode reader has an identified issue, which on presentation of this error may result in two slides erroneously receiving the same stain protocol regardless of what should have been indicated in the software for that keycode. the barcode reader fails to purge previously read barcode information and applies the same protocol details to a subsequent slide.
  • 조치
    Roche is advising users to use same-slide controls as per the package insert and review run reports at the end of each run to ensure the intended staining protocol was used on each slide. Additionally, ensure each host has an adequate keycode range allocated. Roche will be performing a software upgrade as a permanent correction. This action has been closed-out on 26/08/2016.

Device

BenchMark ULTRA with software versions VSS 11.9 or higher, and DISCOVERY ULTRA clinical chemistry...
  • 모델명 / 제조번호(시리얼번호)
    BenchMark ULTRA with software versions VSS 11.9 or higher, and DISCOVERY ULTRA clinical chemistry analysers (used for detecting and preparing tissue morphology and components). An in vitro diagnostic medical device (IVD).BenchMark ULTRA instrument Material Number: 05342716001Software versions VSS 11.9 or higherDISCOVERY ULTRA instrumentMaterial Number: 05987750001ARTG number: 173917
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited