Events

One Step HCG Urine Pregnancy Test. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Murray International Trading 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-2016-RN-00024-2
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-01-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00024-2
  • 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
    Subsequent to complaints regarding false negative results by the users, results of the testing undertaken by the tga for the above batches have showed that these batches do not comply with the claim in the instructions for use which specify that “in less than 5 minutes, levels of hcg as low as 25miu/ml can be detected”. batch # 20150314 has failed to detect hcg in human urine at concentrations of 10, 25, and 50 miu/ml levels while batch # 20140406 has failed at hcg concentrations of 10, 25, 50 and 100 miu/ml . the tga is undertaking further investigation to ascertain if any further actions are required.False negative results in the worst case can result in misdiagnosis and significant harm.
  • 조치
    Customers are advised to quarantine any unused stock from the above batches and return it to Murray International Trading Pty Ltd.

Device

One Step HCG Urine Pregnancy Test. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    One Step HCG Urine Pregnancy Test. An in vitro diagnostic medical device (IVD)Batch Numbers: 20140406 and 20150314ARTG number: 260088
  • Manufacturer
    Murray International Trading Pty Ltd

Manufacturer

Murray International Trading Pty Ltd
  • Source
    DHTGA