Events

Panocell 16 and Panocell 20. 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-2016-RN-00118-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2016-02-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00118-1
  • 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
    Reports have been received concerning unexpected positive reactivity when testing donor n3512 with anti-v. donor n3512 was listed as v– (negative) on the master list supplied with these products. immucor have confirmed that this donor is v+ (positive).
  • 조치
    Seqirus is providing a revised master list which correctly identifies Donor N3512 as V+ (positive). Seqirus is asking users to evaluate the impact the amended phenotype information may have on results generated with these product lots as per the users' procedures. This action has been closed-out on 04/05/2017.

Device

Panocell 16 and Panocell 20. An in vitro diagnostic medical device (IVD).
  • 모델명 / 제조번호(시리얼번호)
    Panocell 16 and Panocell 20. An in vitro diagnostic medical device (IVD).Panocell 16Seqirus Product Item: 2332Pack Size: 1 kit (16 cell panel)Lot Number: 39330Expiry Date: 04/12/2015Panocell 20Seqirus Product Item: 5020Pack Size: 1 kit (20 cell panel)Lot Number: 47436 (expiry 29/01/2016), 23160 (expiry 14/08/2015), 14052 (expiry 12/06/15)ARTG Number: 245555
  • Manufacturer
    bioCSL Pty Ltd

Manufacturer

bioCSL Pty Ltd