ARGENE Adenovirus R-gene and Parechovirus R- Gene Control Kits. (An in vitro diagnostic medical device) 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-2018-RN-00143-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2018-02-20
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    It has been identified that a proportion of kits in the argene range have been mislabelled, where the target name is missing from the tube label. the kits are colour coded by reference to minimise the risk of mixing tubes from different references.
  • 조치
    BioMerieux is advising users that the affected product can continue to be used. Users are reminded that the affected products are colour coded by reference, and include the reference number on the labelling.

Device

  • 모델명 / 제조번호(시리얼번호)
    ARGENE Adenovirus R-gene and Parechovirus R- Gene Control Kits. (An in vitro diagnostic medical device)Adenovirus R-gene Quantification Standard (QS) and Sensitivity Control (SC)Refernece Number: 69-010BLot Number: 1005056960Expiry date: 25/08/2018Parechovirus R-gene Postive control (PC20)Reference Number: 71-020Lot Number: 1005090480Expiry Date: 31/08/2018ARTG Number: 211361 (Biomerieux Australia - Viral infectious disease IVDs)
  • Manufacturer

Manufacturer