Events

VITEK 2 System version 7.01. An in vitro diagnostic medical device (IVD).Bacteria identification and sensitivity system 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-2015-RN-00096-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-02-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00096-1
  • 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
    Biomeriuex has identified that the inoculum density range for the neisseria haemophilus (nh) identification (id) test card in the vitek 2 7.01 product information document (ref: 514740-1en1) is incorrect. in section 6 - procedure for nh card specimen preparation (step 3), the documented densichek plus inoculum density range is 1.80 - 2.20. the correct density range is 2.70 - 3.30.The incorrect information is located on the dvd software for the vitek 2 7.01 system. all other product documentation has the correct inoculum density.
  • 조치
    bioMerieux is advising end users of the incorrect inoculum density range and requesting that the recall letter be kept with the instrument documentation. bioMerieux will update the VITEK 2 7.01 Product Information to include the correct DensiCHEK inoculation concentration. This action has been closed-out on 09/08/2016.

Device

VITEK 2 System version 7.01. An in vitro diagnostic medical device (IVD).Bacteria identification ...
  • 모델명 / 제조번호(시리얼번호)
    VITEK 2 System version 7.01. An in vitro diagnostic medical device (IVD).Bacteria identification and sensitivity system
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd