Events

Conceiveplease One Step HCG Urine Pregnancy test(Included in ConceivePlease Kits) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Conceiveplease 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-00190-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-02-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00190-1
  • 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
    The testing undertaken by the tga for the above batch of conceiveplease one step hcg urine pregnancy test has shown that this batch does not comply with the claim in the instructions for use which specify that "ln less than 5 minutes, levels of hcg as low as 25mlu/ml can be detected".Batch 20131203 failed to detect hcg in human urine at concentrations of 10 and 25miu/ml levels. false negative results in the worst case can result in misdiagnosis, which can have significant consequences. the tga is undertaking further investigations to ascertain if any further actions are required.
  • 조치
    Please note that ConceivePlease Pty Ltd has advised the TGA that only fewer than 100 kits from the affected batch were supplied to retailers during a three week period, from 21 January to 11 February 2016. Customers are advised to quarantine any unused stock from the affected batch and return them to the place of purchase for a refund. For more information please see http://www.tga.gov.au/alert/conceiveplease-one-step-hcg-urine-pregnancy-test . This action has been closed-out on 19/01/2017.

Device

Conceiveplease One Step HCG Urine Pregnancy test(Included in ConceivePlease Kits)
  • 모델명 / 제조번호(시리얼번호)
    Conceiveplease One Step HCG Urine Pregnancy test(Included in ConceivePlease Kits)Batch Number: 20131203Expiry Date: 12 September 2016ARTG Number: 212074
  • Manufacturer
    Conceiveplease Pty Ltd

Manufacturer

Conceiveplease Pty Ltd
  • Source
    DHTGA