Events

Human IgG4 Kit Immage KitProduct code: LK009.IM 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 In Vitro Technologies 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-2014-RN-00991-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-09-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00991-1
  • 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
    As a result of customer complaints, the manufacturer (the binding site) identified that samples containing extremely high igg4 levels exhibit antigen excess and will yield spuriously low igg4 results.
  • 조치
    In Vitro Technologies is advising that care must be taken when interpreting results from patients suspected of suffering from IgG4-RSD and recommend that for any patient where the IgG4 concentration does not concur with their clinical history or other test results, the sample should be re-assayed at different dilutions to identify if any antigen excess is occurring. In addition, the IgG4 result should be equated to the total IgG result and any significant discrepancies investigated. The instructions for use have been updated to include these recommendations. This action has been closed-out on 03/02/2017.

Device

Human IgG4 Kit Immage KitProduct code: LK009.IM
  • 모델명 / 제조번호(시리얼번호)
    Human IgG4 Kit Immage KitProduct code: LK009.IM ARTG Number: 202167
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd