Events

BBL MGIT Mycobacteria Growth Indicator Tube(used for the detection and recovery of mycobacteria including mycobacterium tuberculosis) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Becton Dickinson 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-00975-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-09-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00975-1
  • 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
    Bd has determined that affected bbl mgit tubes were labelled with an incorrect barcode, such that the correct barcode prefix "43 01" was actually printed as "43 02". the manufacturer identified this error prior to supplying the product and over labelled the product with the correct barcode. the manufacturer has identified that the over labels may peel off in varying degrees which exposes the incorrect barcode. this can result in mgit false negative results.
  • 조치
    BD is requesting users to discontinue use and discard any remaining inventory of the affected product. Replacement stock will be provided by BD. The package insert recommends that users perform a visual check of all instrument negative tubes. Tubes that appear to be positive should be sub-cultured, acid-fast stained and treated as a presumptive positive. A review of previously reported results is not required if this protocol is followed.

Device

BBL MGIT Mycobacteria Growth Indicator Tube(used for the detection and recovery of mycobacteria i...
  • 모델명 / 제조번호(시리얼번호)
    BBL MGIT Mycobacteria Growth Indicator Tube(used for the detection and recovery of mycobacteria including mycobacterium tuberculosis)Catalogue Number: 245122Lot Number: 3061013Expiry date: 6 September 2014An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd