Events

Grifols Australia AHG Cards. An in vitro diagnostic medical device (IVD) 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-2013-RN-00947-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-09-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00947-1
  • 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 is undertaking a recall due to a potential finding of higher than expected number of cards with wells showing incorrect level of supernatant or cracked gel when they perform the intiial visual check of the cards as stated in the instructions for use. the origin of the problem is a production incident in the card sealing process where some cards were incorrectly sealed. this issue will induce supernatant evaporation that finally will lead to incorrect supernatant levels or cracked gel.
  • 조치
    End users are requested to quarantine all stock from the affected lot and contact Grifols to arrange for replacement stock. Once replacement stock has been received end users are requested to discard the affected lot in their biological waste.

Device

Grifols Australia AHG Cards. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Grifols Australia AHG Cards. An in vitro diagnostic medical device (IVD)Item Codes: 71300048, 71300504 & 71301008Lot Number: 13059.01Expiration Date: 10/2014ARTG Number: 178738
  • Manufacturer
    Grifols Australia Pty Ltd

Manufacturer

Grifols Australia Pty Ltd