Events

cobas 6800 system - cobas MPX, 96 tests and cobas MPX, 480 tests. An in-vitro diagnostic medical device (IVD). cobas MPX, 96 tests 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-2016-RN-00833-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-06-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00833-1
  • 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
    Roche diagnostics australia is informing users that in extremely rare cases, sample under-aspiration may occur when using the cobas 6800 system with sample input volumes of less than 450 µl. this issue will only affect the cobas mpx test when used with cadaveric donors, since the minimum sample volume required for cadaveric donors is 300 µl (for living donors, the minimum sample volume required is 1,000 µl).If bubbles or foam are present in the sample tube, this may lead to false sample liquid level detection and under-aspiration of the sample. this could potentially cause false negative / under-quantitated results that are not flagged.
  • 조치
    Roche is advising users to ensure good sample preparation technique to avoid the formation of foam, clots, or bubbles in all samples, as described within the instrument safety manual. A look-back at previous cadaveric results is also recommended. Roche will be implementing a software correction as a permanent fix..

Device

cobas 6800 system - cobas MPX, 96 tests and cobas MPX, 480 tests. An in-vitro diagnostic medical ...
  • 모델명 / 제조번호(시리얼번호)
    cobas 6800 system - cobas MPX, 96 tests and cobas MPX, 480 tests. An in-vitro diagnostic medical device (IVD). cobas MPX, 96 testsMaterial Number: 06997708190All Lot Numbers affectedcobas MPX, 480 testsMaterial Number: 06997716190All Lot Numbers affectedARTG Number: 275469
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited