Events

EliA SmDP Well 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-00013-2
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-01-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00013-2
  • 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
    There have been unusually high numbers of positive results with elia smdp well lots, which are not due to anti-sm antibodies.All equivocal and positive patient sample results measured with lots 0018 and 0019 are potentially incorrect and are thus considered to be invalid. a false positive result could lead to unnecessary treatment/procedures.There is no indication that negative results generated with elia smdp well lots 0018 and 0019 are affected.
  • 조치
    This action has been closed out 08 Jun 2017.

Device

EliA SmDP Well
  • 모델명 / 제조번호(시리얼번호)
    EliA SmDP WellPart Number: 14-562-01Lot Numbers: 0018 and 0019Expiry Dates 30 November 2016 and 31 March 2017ARTG Number: 229585
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd