Events

VITEK 2 Gram-Positive (GP) Identification (ID) Test Kit. 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-2017-RN-01333-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-11-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01333-1
  • 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
    Biomérieux have received customer reports indicating occurrences of atypical negative o129r reactions for enterococcus casseliflavus atcc 700327 in association with specific vitek 2 gp id lots, causing failure of the quality control (qc) testing for the vitek 2 gp id card. the expected o129r reaction for atcc 700327 strain is positive.An internal investigation determined that a positive dsor reaction that occurs early in the incubation of the card is causing an earlier end to the analysis of the card leading to an atypical negative reaction for o129r.
  • 조치
    bioMérieux is advising users to review inventory and discard any remaining stocks of the affected lots. A review of previously generated results is at the discretion of the Laboratory Manager.

Device

VITEK 2 Gram-Positive (GP) Identification (ID) Test Kit. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    VITEK 2 Gram-Positive (GP) Identification (ID) Test Kit. An in vitro diagnostic medical device (IVD)Batch/Lot Number: 2420192403Expiry: 06 June 2018Batch/Lot Number: 2420198203Expiry: 12 June 2018ARTG Number: 215320
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd