Various ID-Diacell Products. An in vitro diagnostic medical device (IVD).ID-DiaCell PoolID-DiaCell ABO/I-II ID-DiaCell ABO/I-II-III ID-DiaCell I-IIID-DiaPanelID-DiaCell I-II-IIIID-DiaCell I-II-III AsiaID-DiaScreen ProphylaxID-DiaPanel Plus 6ID-DiaCell ABOID-DiaCell lP-llP-lllPID-DiaPanel-P 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Bio-Rad Laboratories 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-2017-RN-00241-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-02-28
  • 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
    Bio-rad has identified an issue in relation to unexpected reactions primarily on eluates and qc samples but also with some patient samples when using id-diacell products. there is the potential for false positive results.
  • 조치
    Bio Rad Laboratories is advising users to re-test with a new kit if they are doubtful of the results and if doubts remain after re-testing, to use an alternative testing method. Users are further advised to disseminate this information to relevant personnel within their facilities.

Device

  • 모델명 / 제조번호(시리얼번호)
    Various ID-Diacell Products. An in vitro diagnostic medical device (IVD).ID-DiaCell PoolID-DiaCell ABO/I-II ID-DiaCell ABO/I-II-III ID-DiaCell I-IIID-DiaPanelID-DiaCell I-II-IIIID-DiaCell I-II-III AsiaID-DiaScreen ProphylaxID-DiaPanel Plus 6ID-DiaCell ABOID-DiaCell lP-llP-lllPID-DiaPanel-P Multiple Catalogue NumbersAll unexpired lotsARTG Number: 213161
  • Manufacturer

Manufacturer