Events

VITEK MS, firmware version 3.10 and 3.13 (bacterial and fungal identification system which uses the matrix-assisted laser desorption / ionization (MALDI) mass spectrometry method) (an in vitro diagnostic medical device (IVD)) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Biomerieux 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-2013-RN-01051-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-10-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01051-1
  • 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
    Some issues have been reported when firmware version 3.13 was installed on systems equipped with the old transient recorder (tr) board (ref. 6200350). extensive testing has proven that firmware 3.13 may potentially cause an instrument to freeze or hang during acquisition when installed with the old tr board, with a risk of repeated results for different spots. this issue does not occur if firmware version 3.13 is installed with the new tr board ae8679ad (ref. 6200720).
  • 조치
    Biomerieux is requesting users to reboot the instrument if the board freezes. Biomerieux is advising users that the new TR board is required to have firmware V3.13, and the old TR board is required to have firmware version V3.10. Biomerieux is contacting users to migrate the firmware if required.

Device

VITEK MS, firmware version 3.10 and 3.13 (bacterial and fungal identification system which uses t...
  • 모델명 / 제조번호(시리얼번호)
    VITEK MS, firmware version 3.10 and 3.13 (bacterial and fungal identification system which uses the matrix-assisted laser desorption / ionization (MALDI) mass spectrometry method) (an in vitro diagnostic medical device (IVD))Catalogue Number: 410895Serial Numbers: Lower than #50039, #50050, greater than or equal to #60000ARTG Number: 199422
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd