Events

ZYM B, API Listeria and API NH (bacterial identification reagents and kits). 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-01186-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-11-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01186-1
  • 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 identified a visual defect and activity issue on the zym b reagent (reference 70493) which is used as an additional test for revealing the results of some miniaturised biochemical tests. further investigations performed by biomerieux quality control laboratory confirmed an activity issue on zym b reagent. this activity issue lead to a false negative result of some api biochemical tests using the zym b reagent. investigations are still in progress in order to identify the root cause.
  • 조치
    BioMerieux is advising end users to discard any ampoule of ZYM B with a visual defect (as described in the IFU). For units of ZYM B without the visual defect, end users are requested to carry out additional QC when using the potentially affected API kits. If QC fails the kits are to be discarded. Alternatively any kits of ZYM B can be discarded and replaced by bioMerieux.

Device

ZYM B, API Listeria and API NH (bacterial identification reagents and kits). An in vitro diagnost...
  • 모델명 / 제조번호(시리얼번호)
    ZYM B, API Listeria and API NH (bacterial identification reagents and kits). An in vitro diagnostic medical device (IVD)ZYM B reagent (Ref Number: 70493)Multiple lot numbers affectedUsed as an additional test in:- API 20 Strep (Ref Number: 20600)- API Coryne (Ref Number: 20900)- API Staph (Ref Number: 20500)- API ZYM (Ref Number: 25200)API NH (Ref Number: 10400)Multiple lot numbers affectedAPI Listeria (Ref Number: 10300)Multiple lot numbers affected
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd