Events

LIAISON Borrelia IgG. An in vitro diagnostic medical device (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 DiaSorin 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-2014-RN-01240-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-11-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01240-1
  • 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
    Diasorin has become aware that the kit lots identified have a potential to produce invalid calibrations due to either a calibrator 1 deviation percentage [%] outside the high limit, or due to the gcc (geometrical curve check) out of range. as a consequence the calibration cannot be validated and the testing with these lots on the analyser cannot be performed.
  • 조치
    Diasorin is recommending that use of the affected lot be ceased and any units be discarded. Results obtained with a valid calibration are considered to be reliable; therefore, review of past patient results is not deemed necessary, but at the discretion of the laboratory director. This action has been closed-out on 01/03/2016.

Device

LIAISON Borrelia IgG. An in vitro diagnostic medical device (IVD).
  • 모델명 / 제조번호(시리얼번호)
    LIAISON Borrelia IgG. An in vitro diagnostic medical device (IVD).Part number: 310880Lot Number: 089054X , 089054X/1 and 089054X/2Expiry date January 9th, 2016 for all three lots ARTG number: 208811
  • Manufacturer
    DiaSorin Australia Pty Ltd

Manufacturer

DiaSorin Australia Pty Ltd