ABC1 HLA Typing Tray included in ABC1 / ABC2 Kits. An in vitro diagnostic medical device (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Diagnostic Solutions 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-00169-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-02-08
  • 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
    Abc1 hla typing trays included in a single lot of acb1/acb2 kits contain a manufacturing defect that can result in false positive or false negative results.
  • 조치
    Diagnostic Solutions is advising customers to immediately discontinue use of and destroy ABC1 HLA Typing Trays from the affected lot. Replacement kits will be provided. It is recommended that previously reported results are reviewed at the discretion of the clinical or laboratory director. This action has been closed out on 16 June 2017.

Device

  • 모델명 / 제조번호(시리얼번호)
    ABC1 HLA Typing Tray included in ABC1 / ABC2 Kits. An in vitro diagnostic medical device (IVD).Product Code: GT-ABC1/2AULot Number: 3004753Expiration Date: 15 Nov 2017ARTG Number: 236406
  • Manufacturer

Manufacturer