Events

AcroMetrix PeliSpy Sero Control Type 36 and Type 38. 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-2013-RN-00084-2
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-01-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00084-2
  • 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
    The manufacturer of pelispy sero control type 36 and type 38 advises that affected lots may produce signal to cut-off (s/co) ratios <1 when run on the prism hbsag assay. consequently, if these lots are implemented as a go-no-go control using a threshold s/co ratio of 1 in the prism hbsag assay, test runs may need to be failed.
  • 조치
    Life Technologies is requesting users to inspect and quarantine any affected lots. Arrangements for stock recovery and replacement will be arranged upon confirmation of affected units.

Device

AcroMetrix PeliSpy Sero Control Type 36 and Type 38. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    AcroMetrix PeliSpy Sero Control Type 36 and Type 38. An in vitro diagnostic medical device (IVD)Type 36Catalogue number: 964608 and S2381Lot numbers: 201305 (Expiry date: 01/2014) and 035717 (Expiry date: 03/2013) Type 38Catalogue number : 964609 and S2404Lot numbers : 035716 (Expiry date: 01/2014) and 220905 (Expiry date: 08/2014)ARTG Number: 192532
  • Manufacturer
    Life Technologies Australia Pty Ltd

Manufacturer

Life Technologies Australia Pty Ltd