Events

Coxiella burnetii IFA IgG Kit 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Abacus ALS 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-01149-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-09-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01149-1
  • 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
    Some coxiella burnetii ifa igg slides in kits from lot number 15c403 are labelled “leishmania infantum” instead of “coxiella burnetii”. the affected slides, while showing the inscription leishmania infantum, are coated with coxiella burnetii antigen and have the same features and performance as the slides labelled correctly with the coxiella burnetii inscription. of the slides checked by vircell, only 0.3% present with this labelling anomaly.
  • 조치
    Abacus ALS is advising users to cease use of stock with the affected lot number. Abacus will replace affected stock with unaffected stock. A look back of previous results is at the discretion of the laboratory director. This action has been closed out on 13 Jun 2017.

Device

Coxiella burnetii IFA IgG Kit
  • 모델명 / 제조번호(시리얼번호)
    Coxiella burnetii IFA IgG KitReference Number: PCOBUGKit Lot Number: 15C304Slide Lot Number: 15C403ARTG Number: 212957An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd