Events

Randox Liquid Assayed Specific Protein Controls. 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-00508-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-05-31
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00508-1
  • 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 confirmed that free kappa light chains in certain liquid assayed specific protein controls increase over the shelf life of the product. the quality control results which are not within range can lead to a delay in reporting free kappa light chains results.Free kappa light chains are used as an aid in diagnosis of monoclonal gammopathy of undetermined significance and for multiple myeloma through review of the ratio with free lamda chains. a short delay in reporting this result is unlikely to prevent diagnosis of these progressive diseases and therefore is unlikely to pose an immediate risk to health.
  • 조치
    Randox is advising users to be aware of the issue and place the Customer Letter with any remaining kits. A revised IFU is also being supplied to users which outlines this issue to users under "Storage and Stability".

Device

Randox Liquid Assayed Specific Protein Controls. An in vitro diagnostic medical device (IVD).
  • 모델명 / 제조번호(시리얼번호)
    Randox Liquid Assayed Specific Protein Controls. An in vitro diagnostic medical device (IVD). Catalogue Number: PS2682GTIN: 05055273204896Catalogue Number: PS2683GTIN: 05055273204902Catalogue Number: PS2684GTIN: 05055273204919ARTG Number: 199684
  • Manufacturer
    Randox Australia Pty Ltd

Manufacturer

Randox Australia Pty Ltd
  • Source
    DHTGA