Events

Parechovirus r-gene. 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-2015-RN-00579-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-06-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00579-1
  • 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
    An internal investigation identified a shift of the ct values of lnternal control (ic1 w0, internal control with water) inside and outside the limit of specifications. the investigations performed by r&d; with ref. 71-020 lot 1002978600 showed that ct values results on the extraction control (ic1w0) with ct value close to the specification of validity (32 ct) or just above this specification. the ct shift values may be observed on a positive sample without impacting the limit of detection.
  • 조치
    Biomerieux is requesting their customers to discontinue using and discard any remaining inventory of the Parechovirus r-gene ref. 71-020 (WW) lot 1002978600. This action has been closed-out on 17/08/2016.

Device

Parechovirus r-gene. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Parechovirus r-gene. An in vitro diagnostic medical device (IVD)Catalogue Number: 71-020Serial Number: 1002978600Supplied as Research Use OnlyARTG Number: 211361
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd