Events

Grifols Australia Perfect Panel cells 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Grifols 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-01020-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-09-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01020-1
  • 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
    Grifols australia wishes to advise of an error identified on the antigen composition sheet for perfect panel.The antigen composition sheet supplied with the affected lots of product states cell no. 6 as donor no.154. the antigen composition sheet should state cell no. 6 as donor no. 213 and the corresponding phenotypic profile.
  • 조치
    Grifols Australia is providing their customers with the correct Antigen Composition Sheet with the recall action correspondence. This action has been closed-out on 06/06/2016.

Device

Grifols Australia Perfect Panel cells
  • 모델명 / 제조번호(시리얼번호)
    Grifols Australia Perfect Panel cellsProduct Codes: 904114, 904125, 904114L, 904125L, 904114TSet Lot Numbers: 904114.04.2, 904125.04.2, 904114L.04.2, 904125L.04.2 and 904114T.73.1Expiry date: 17/11/2014ARTG number: 178738
  • Manufacturer
    Grifols Australia Pty Ltd

Manufacturer

Grifols Australia Pty Ltd