Events

FB Reagent, ZYM B Reagent, API Listeria and API NHFB Reagent 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-2014-RN-00293-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-03-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00293-1
  • 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 the quality control of new lot of fb reagent, a visual defect (colour issue) was observed. the first investigation performed by the manufacturing site showed that this visual defect is due to a specific lot of raw material used for the manufacturing of this fb reagent. in addition, this lot of raw material has also been used for the manufacturing of several lots of fb reagent and zym b reagent using the same raw material than the fb reagent. as the involved lots of zym b reagent are included inside of api nh and api listeria kits, the both references are also impacted.
  • 조치
    BioMeriuex is requesting their customers to discontinue use and discard any stock with visual defects. Testing using the affected lost can continue if daily QC is run using a validated ATCC strain.

Device

FB Reagent, ZYM B Reagent, API Listeria and API NHFB Reagent
  • 모델명 / 제조번호(시리얼번호)
    FB Reagent, ZYM B Reagent, API Listeria and API NHFB ReagentReference Number: 70562ZYM B reagentReference Number: 70493API NHReference Number: 10400API ListeriaReference Number: 10300Multiple lot numbers affected
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd