Events

VITEK® 2 Identification / Antimicrobial Susceptibility Test Cards 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 BioMerieux Inc 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
    21681
  • 사례 시작날짜
    2017-07-12
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Medi'Ray New Zealand Ltd, 53-55 Paul Matthews Road, Albany, Auckland 0632
  • 원인
    A potential issue was identified related to the white pouch which contains vitek® test cards. the manufacturer has determined that the integrity of some of the vitek® 2 test card pouches may be compromised. based on investigation, a compromised test card pouch can impact card reagents due to the entry of moisture.
  • 조치
    Manufacturer to issue advice regarding use

Device

VITEK® 2 Identification / Antimicrobial Susceptibility Test Cards
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: VITEK 2 GN ID, VITEK 2 GP ID, VITEK 2 BCL ID, VITEK 2 NH ID, VITEK 2 ANC ID, VITEK 2 AST GP69, VITEK 2 AST P612, VITEK 2 AST ST01, VITEK 2 AST GN65, VITEK 2 AST N246, VITEK 2 AST GN82, VITEK 2 AST YS07, VITEK 2 AST N311, VITEK 2 AST GP76
  • Manufacturer
    BioMerieux Inc

Manufacturer

BioMerieux Inc