LABType DNA Typing Tests (for transplant compatibility analysis). An in vitro diagnostic medical device (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Bio-Strategy 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-01380-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-05-17
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    Lot specific user documents and catalog files updated for the january 2016 nomenclature contain incorrect allele specificity information for certain beads for particular labtype dna typing tests. the affected documents and catalog files were accessible between the date period july 29, 2016 to august 22, 2016.
  • 조치
    Bio-Strategy has provided customers with corrected lot-specific user documents and catalog files, and advised that results obtained using the affected products and incorrect user documents and catalog files should be reviewed using the corrected information. This action has been closed-out on 17/05/2017.

Device

  • 모델명 / 제조번호(시리얼번호)
    LABType DNA Typing Tests (for transplant compatibility analysis). An in vitro diagnostic medical device (IVD).SSO Class II DRB1 (Catalog ID: RSSO2B1, RS02B1T)HD Class II DRB1 (ID: RSSOH2B1, RSOH2B1T, RSSOH2B1X)SSO Class II DQA1/DQB1 (ID: RSSO2Q, RSSO2QX, RSO2QT)SSO MICA (ID: RSSOMICA)SSO Class I Bw4 Supplement (ID: RSSO1S4, RSO1S4T)XR Class II DRB1 (ID: RSSOX2B1, RSOX2B1T)CWD Class II DRB1 (ID: RSSOW2B1, RSOW2B1T)Multiple lots affected.ARTG Numbers: 236737 & 236738
  • Manufacturer

Manufacturer