Events

Haemophilus Test medium (HTM). 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-2017-RN-00831-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-07-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00831-1
  • 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
    Biomérieux have received reports regarding an issue with the use of the 04054 haemophilus test medium. (lot number hdk-206). the issue is related to the media not supporting the growth of haemophilus influenza isolates (atcc 49766 and atcc 49247).
  • 조치
    bioMérieux is requesting Customers cease using lot number HDK-206 (04054 Haemophilus Test medium). It is also recommended that results which have an ongoing clinical impact be re- examined using a different lot number of 04054 Haemophilus Test medium. Distribute this information to all appropriate personnel in your laboratory including others to whom you may have transferred the product, retain a copy in your files. 2. Discuss any concerns you may have regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action. 3. Quarantine inventory of 04054 Haemophilus Test medium (HTM) for Lot # HDK-206 and discard all affected products in an appropriate manner. Please complete and return the acknowledgement form to qa.anz@biomerieux.com to confirm receipt and credit.

Device

Haemophilus Test medium (HTM). An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Haemophilus Test medium (HTM). An in vitro diagnostic medical device (IVD)Product Number: 04054Lot Number: HDK-206ARTG Number: 201986
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd