Events

Human IgM kit for use on SPAPLUS 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-2017-RN-00916-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-08-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00916-1
  • 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
    An investigation by in vitro technologies investigations of specific lots of human igm kit for use on spaplus have identified that the calibration stability has decreased in comparison to historical released kits. users will be able to identify when the calibration is no longer valid, as control values will fall outside of the provided acceptable limits.
  • 조치
    The Binding Site recommends the following: 1. Batch sample analysis, when possible; 2. Recalibrate the assay when QC results have deviated outside of the specified range; 3. Contact In Vitro Technologies for any further guidance or additional kit requirements; and 4. Complete the acknowledgement form supplied with the customer letter, even if you do not have any of the affected product, and return it by email to QRA@invitro.com.au

Device

Human IgM kit for use on SPAPLUS
  • 모델명 / 제조번호(시리얼번호)
    Human IgM kit for use on SPAPLUSItem Number: TBSNK012SLot Numbers: 400872 and 407480ARTG Number: 202167
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd