Red Blood Cell Antibody Identification Reagent - Phenocell C 0.8% and Phenocell C 3%. An in vitro diagnostic medical device (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 bioCSL 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-2013-RN-00638-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2013-06-28
  • 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
    The antigen composition sheet supplied with the product listed cell 5 as lu-a negative. however, a customer complaint was received from the imvs adelaide red cell reference laboratory that they typed cell 5 as lua positive. confirmatory testing performed by biocsl in response to the customer complaint has confirmed that cell 5 does type as lu-a positive (weak reaction – score 5 (0-12 scale)).
  • 조치
    bioCSL is providing end users with an updated Antigen Composition Sheets for affected kits. The updated information is also provided online at www.biocsl.com.au/IH

Device

  • 모델명 / 제조번호(시리얼번호)
    Red Blood Cell Antibody Identification Reagent - Phenocell C 0.8% and Phenocell C 3%. An in vitro diagnostic medical device (IVD).Phenocell C 0.8%Catalogue number: 96530201Lot number: 9653 052Phenocell C 3%Catalogue number: 86640201Lot number: 8664 052
  • Manufacturer

Manufacturer