Events

Phenocell B 0.8% and 3% and Abtectcell III 0.8%RhD. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Seqirus 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-00658-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-06-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00658-1
  • 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
    Seqirus has identified that donor #4138503 was listed as d - (negative) on the antigen composition sheet(s) provided with the affected products. subsequent testing of this donor has indicated weak d reactivity. donor #4138503 may be agglutinated by some examples of anti d and the weak d antigen expression of this donor is only detectable by some test methods. this donor has been identified as a possible weak d variant.
  • 조치
    Seqirus has provided users with an interim workaround in the Customer Letter.

Device

Phenocell B 0.8% and 3% and Abtectcell III 0.8%RhD. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Phenocell B 0.8% and 3% and Abtectcell III 0.8%RhD. An in vitro diagnostic medical device (IVD)Phenocell B 0.8%Item Number: 26530201Lot Number: 2653164Cell Number: Cell #6Phenocell B 3%Item Number: 16640201Lot Number: 1664164Cell Number: Cell #6Abtectcell III 0.8% RhD Negative Screening CellsItem Number: 22230201Lot Number: 2223123Cell Number: Cell #1Expiry Date: 12/06/2017ARTG Number: 223867
  • Manufacturer
    Seqirus Pty Ltd

Manufacturer

Seqirus Pty Ltd