Events

RAPID Hp StAR Kit (used in the detection of H. pylori). An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Thermo Fisher Scientific Australia & New Zealand 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-2016-RN-00620-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-05-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00620-1
  • 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 technical investigation by oxoid limited, has identified that the affected lot may give a weak false positive line with no h. pylori antigen present, making interpretation of test results more difficult than with previous batches. continued use of this lot may result in a delayed or false positive results reporting.
  • 조치
    Thermo Fisher is advising users to inspect stock and remove any remaining product of the affected lot number from use. A credit note will be issued. A review of previously generated patient results is at the discretion of the Laboratory Director. This action has been closed-out on 03/02/2017.

Device

RAPID Hp StAR Kit (used in the detection of H. pylori). An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    RAPID Hp StAR Kit (used in the detection of H. pylori). An in vitro diagnostic medical device (IVD)Product Code: K671411-2Lot Number: HP1115ARTG Number: 235688
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand