Events

Freelite Human Lambda Free 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-2016-RN-01425-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-11-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01425-1
  • 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
    The manufacturer has advised that investigations of the products have identified a change in the calibration curve shape that has occurred since product release. increased activity in the calibration curve between calibrators 5 and 6 has been observed and they have received reports of increased false prozone flags which is consistent with this issue.
  • 조치
    Customers are advised to immediately quarantine and dispose of any affected lots held by the customers and also to remove any affected lots from the SPAPLUS instrument. It is also advised to discuss the issues with the Medical Director to identify any further actions are required including reviewing the previously reported results.

Device

Freelite Human Lambda Free kit for use on SPAPLUS
  • 모델명 / 제조번호(시리얼번호)
    Freelite Human Lambda Free kit for use on SPAPLUSItem Numbers: TBSLK018S, TBSLK01810SLot Numbers: 400012, 400257Expiry: Nov 2017
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd