Events

chromID S.aureus agar (SAID/MRSA). 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-2015-RN-00804-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-08-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00804-1
  • 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
    During an internal investigation, biomérieux observed an anomaly on nine (9) lots of chromid s. aureus manufactured with the same semi-finished lot.This anomaly is causing a delayed colouration of the colonies which appear white/light green instead of green resulting in a potential false negative result. biochemical and/or immunological tests must be performed to identify colonies other than green ones (white, pink or mauve): therefore, the risk of delivering a false negative result is mitigated if the instructions for use have been followed.
  • 조치
    Biomerieux is advising users to discontinue use and discard any remaining inventory of the affected product. Biomerieux advises that users should discuss any concerns regarding previously reported results with the Laboratory Medical Director to determine the appropriate course of action. This action has been closed-out on 18/08/2016.

Device

chromID S.aureus agar (SAID/MRSA). An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    chromID S.aureus agar (SAID/MRSA). An in vitro diagnostic medical device (IVD)chromID S.aureus agar (SAID)Lot Numbers: 1004119200, 1004044190, 1004085400chromID MRSA agar / chromID S. aureus agar (MRSA/SAID)Lot Numbers: 1004158090, 1004091980, 1004113000, 1004141170ARTG Number: 182081An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd