Events

BacT/ALERT PF Plus Culture Bottle. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Biomerieux 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-00913-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2013-08-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00913-1
  • 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
    Bact/alert pf plus culture bottle, lot 1033298, yielded reflectance results above the stability specification at the 9-month time frame. bottles that have reflectance results near or greater than the initial value threshold specification when first loaded on the instrument could have an increased probability of false positive results.
  • 조치
    Bio Merieux is requesting their customers to discontinue use of the affected batch remaining in stock. Bottles that are already inoculated or incubating should be allowed to complete their testing/incubation. All bottles flagged positive by the instrument should continue to be treated as stated in the instructions for use.

Device

BacT/ALERT PF Plus Culture Bottle. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    BacT/ALERT PF Plus Culture Bottle. An in vitro diagnostic medical device (IVD)Catalogue Number: 410853Lot Number: 1033298Expiration Date: 16 October 2013
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd