Dynabeads HLA (Human Leucocyte Antigen) Class II (an in vitro diagnostic medical device)(reagent used for the isolation of HLA Class II+ cells from human peripheral blood) 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-2014-RN-00416-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-04-08
  • 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
    The manufacturer of dynabeads hla class ii, life technologies as, advises that the listed lots have decreased antibody performance and may not isolate sufficient levels of hla class ii cells required for further testing. lot 142281200 is still within specification, however testing has indicated that it might lose reactivity prior to its expiry date.
  • 조치
    Life Technologies is requesting their customers to inspect their stock and dispose of all units from the affected lots. Lot 142281200 can continue to be used until replacement stock is available.

Device

  • 모델명 / 제조번호(시리얼번호)
    Dynabeads HLA (Human Leucocyte Antigen) Class II (an in vitro diagnostic medical device)(reagent used for the isolation of HLA Class II+ cells from human peripheral blood)Catalogue Number: 21004DLot Numbers: 135384110 (Expiry Date: 09/2014)142281200 (Expiry Date: 02/2015)ARTG Number: 212748
  • Manufacturer

Manufacturer