VITEK MS Clinical Systems. 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-00909-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-08-03
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    The vitek ms system could give, in specific conditions, an incorrect identification result if the tested species is not included in the vitek ms knowledge base (kb). when the microorganism tested is not part of the training dataset, no specific species pattern will be available in the database for comparison. consequently, the system can give:1) no identification when the spectrum acquired does not match with any species pattern.2) a low discrimination identification when the spectrum acquired presents a high level of similarity with multiple specific species patterns present in the database.3) an incorrect single choice identification to the nearest pattern species when the spectrum acquired presents a high level of similarity with a specific species pattern present in the database.This is a system limitation with all maldi-tof databases which is currently not described in the user manual.
  • 조치
    Biomerieux is requesting customers: 1. Distribute the supplied information to all appropriate personnel in your laboratory, retain a copy in your files, and forward the customer letter to all parties that may use this product, including others to whom you may have transferred our product; 2. Take this limitation into account; 3. Contact your local Customer Service in case of questions; and 4. Complete and return the supplied Acknowledgement Form in Attachment A by Fax to confirm receipt of this notice

Device

  • 모델명 / 제조번호(시리얼번호)
    VITEK MS Clinical Systems. An in vitro diagnostic medical device (IVD)Reference Number: 410895Software version: V2 / KB CLI_2.0 ex-US Acquisition station: V2.0 : ref 411032ARTG Number: 199422
  • Manufacturer

Manufacturer