Events

Spot-light Tissue Pre-treatment Kit (Antigen retrieval reagent used in cellular imaging). An in vitro diagnostic medical device (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Life Technologies 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-2016-RN-01413-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2016-11-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01413-1
  • 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
    It has been identified that the enzyme digestion reagent (reagent 2) contains 1.3x the normal amount of enzyme (pepsin) leading to excessive pepsinisation of cells. this may cause loss of tumour cell morphology and inadequate hybridization of fish/cish probes. the over pepsinisation will be obvious to the user when examining slides under a microscope.
  • 조치
    Life Technologies is advising users to dispose of affected stock. Credit will be issued for the affected stock. Unaffected stock is expected to be available from 31 November 2016. This action has been closed-out on 18/05/2017.

Device

Spot-light Tissue Pre-treatment Kit (Antigen retrieval reagent used in cellular imaging). An in v...
  • 모델명 / 제조번호(시리얼번호)
    Spot-light Tissue Pre-treatment Kit (Antigen retrieval reagent used in cellular imaging). An in vitro diagnostic medical device (IVD).Catalogue Number: 008401Lot Numbers: 1667961A (exp. 31 Jul 2016), 1713166A (exp. 30 Nov 2016), 1714439A (exp. 30 Apr 2017), 1763308A (exp. 28 Feb 2018)ARTG Number: 212745
  • Manufacturer
    Life Technologies Australia Pty Ltd

Manufacturer

Life Technologies Australia Pty Ltd