Events

cobas 8000 modular analyser series, control unit software version 03-03 (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-2013-RN-00293-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-04-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00293-1
  • 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
    When using the automatic dilution function on cobas e 602, a software bug occurs leading to an incorrect diluent being used during operation on certain elecsys assays. this happens when all three of the following conditions are present concurrently:- a total of > 2000 reagents kits or diluents had been registered on the cobas e 602 modules within one configuration; and- two or more different diluent types are available on board on the instrument (eg. diluent universal and diluent multiassay); and- a previous diluent (eg diluent universal) had been registered in the database with the identical key information has the current diluent of a different type (eg diluent multiassay).
  • 조치
    Roche is providing work around instructions and a software correction is being developed.

Device

cobas 8000 modular analyser series, control unit software version 03-03 (An in vitro diagnostic m...
  • 모델명 / 제조번호(시리얼번호)
    cobas 8000 modular analyser series, control unit software version 03-03 (An in vitro diagnostic medical device (IVD)) Affected Elecsys assays and their catalogue numbers:CA 15-3 II (03045838122)CMV IgM (04784618190)Anti-HAV IgM (11820591122)Anti-HBc IgM (11820567122)Rubella IgM (04618831190)Toxo IgM (04618858190)CMV IgG Avidity (05909708190)Cortisol (11875116122)Estradiol II (03000079190)N-MID Osteocalcin (12149133122)Toxo IgG (04618815190)
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited