Events

Immunoassay Premium and Premium Plus controls when used with ACTH assays. 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-2017-RN-01067-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-08-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01067-1
  • 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 has confirmed that acth in immunoassay premium plus quality control and immunoassay premium quality control does not meet the quoted reconstituted stability claim in the product ifu. randox now recommends that acth is to be assayed immediately after the 30-minute reconstitution procedure.The quality control results which are not within range can lead to a delay in reporting acth results. acth is typically measured to aid in diagnosing the cause of abnormal cortisol. abnormal cortisol levels are generally not associated with immediate life threatening disorders. therefore a delay in acth reporting is unlikely to pose a serious risk to health.
  • 조치
    1. Place a copy of the supplied notice in all impacted control kits, advising to assay ACTH immediately after the reconstitution procedure is complete. 2. Discuss the contents of the notice with the Medical Director.

Device

Immunoassay Premium and Premium Plus controls when used with ACTH assays. An in vitro diagnostic ...
  • 모델명 / 제조번호(시리얼번호)
    Immunoassay Premium and Premium Plus controls when used with ACTH assays. An in vitro diagnostic medical device (IVD)Immunoassay Premium Quality ControlsCatalogue Number: IA2633Lot Numbers: 402366, 398703Immunoassay Premium Plus Quality ControlsCatalogue Number: IA3109 Lot Numbers: 1573EC, 1619EC Catalogue Number: IA3110 Lot Number: 1477ECCatalogue Number: IA3111 Lot Numbers: 1478EC, 1578ECCatalogue Number: IA3112Lot Number: 377412, 398901ARTG Number: 206767
  • Manufacturer
    Randox Australia Pty Ltd

Manufacturer

Randox Australia Pty Ltd
  • Source
    DHTGA