Events

Glucose GLUC-PAP. An in-vitro diagnostic medical device (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Randox 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-2016-RN-01642-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-12-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01642-1
  • 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
    Randox confirms a transcription error when quoting the concentration in g/l for glucose standard lot 2082gl. the correct value should state 0.98g/l.The risk to health when this issue occurs is the potential for reporting incorrect elevated glucose results. however this is highly unlikely as quality control results would also be elevated by a factor of ten.
  • 조치
    Randox is requesting users; 1. Replace the kit IFU with the correct revision as attached to the customer letter; 2. Discuss the contents of the notice with your Medical Director; and 3. Complete and return the vigilance response form provided.

Device

Glucose GLUC-PAP. An in-vitro diagnostic medical device (IVD).
  • 모델명 / 제조번호(시리얼번호)
    Glucose GLUC-PAP. An in-vitro diagnostic medical device (IVD).Catalogue Number: GL1021GTIN: 05055273203165Batch/Lot Number: 385671Expiry Date: 28th Jan 2019ARTG Number: 199617
  • Manufacturer
    Randox Australia Pty Ltd

Manufacturer

Randox Australia Pty Ltd
  • Source
    DHTGA