Events

Polymer Refine Red Detection (used for testing and identification of neoplasm). An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Leica Biosystems Melbourne 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-2015-RN-01206-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-12-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01206-1
  • 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
    Leica biosystems recently became aware that some detection kits may have been subject to a manufacturing error where some containers were under-filled and topped up with the incorrect reagent, leading to inadequate staining. if the product is used according to the instructions for use with the adequate controls, the end user would be able to identify the test has not stained correctly.
  • 조치
    Leica Biosystems is advising users to discontinue use of the affected lot numbers and destroy any remaining stock. Leica Biosystems is recommending consulting with the Laboratory Director and Physician to determine if a review of past results is warranted. This action has been closed-out on 29/08/2016.

Device

Polymer Refine Red Detection (used for testing and identification of neoplasm). An in vitro diagn...
  • 모델명 / 제조번호(시리얼번호)
    Polymer Refine Red Detection (used for testing and identification of neoplasm). An in vitro diagnostic medical device (IVD)Product Code: DS9390Lot Number: 41872 Expiry date: November 2016ARTG Number: 211376
  • Manufacturer
    Leica Biosystems Melbourne Pty Ltd

Manufacturer

Leica Biosystems Melbourne Pty Ltd