Events

Randox Lipase Reagents for use on RX instruments. 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-2018-RN-00239-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-03-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00239-1
  • 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 have identified that the reagent triglycerides can cause elevated lipase results when the lipase reagent is run after triglycerides within the same run. this can affect a qc or patient sample test result. randox have now released further steps for contamination avoidance with the lipase assay on rx instruments. users should refer to the instrument testing order specifically arranging chemistries so that lipase and triglycerides are the last two chemistries in the test running order.In the event of an extremely elevated lipase result, cuvette maintenance steps should be performed as recommended for each rx system. the sample should then be re-tested running the lipase assay in isolation.
  • 조치
    Randox is advising customers and distributors to amend their test running order and update the RX analyser operator manual with the revised information. Updated IFU's will be provided to users. In the event of an extremely elevated Lipase result, cuvette maintenance steps should be performed as recommended for each RX system. The sample should then be re-tested running the Lipase assay in isolation.

Device

Randox Lipase Reagents for use on RX instruments. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Randox Lipase Reagents for use on RX instruments. An in vitro diagnostic medical device (IVD)Catalogue Numbers: LI7979, LI8050ARTG Number: 199615(Randox Australia - Clinical chemistry enzyme IVDs)
  • Manufacturer
    Randox Australia Pty Ltd

Manufacturer

Randox Australia Pty Ltd
  • Source
    DHTGA