Events

Horse Blood Agar. 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-2018-RN-00353-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2018-05-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00353-1
  • 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 has identified an issue at their brisbane culture media manufacturing site regarding product reference number 04059, lot number jcu-203, horse blood agar. during post release testing a potential contamination issue (contaminated deep and surface) has been identified. the microorganism was identified as a gram positive bacilli.
  • 조치
    bioMérieux is requesting that Laboratories should: 1.Stop using HBA ref. 04059, Lot JCU-203 and segregate the product and discard/dispose appropriately under the relevant laboratory guidelines; 2.Complete and return Attachment A from the customer letter to qa.anz@biomerieux.com in order to confirm receipt; and 3.Contact your local bioMérieux representative for product compensation as necessary.

Device

Horse Blood Agar. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Horse Blood Agar. An in vitro diagnostic medical device (IVD)Reference Number: 04059Lot Number: JCU-203ARTG Number: :201986
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd