Events

Vitros Chemistry products K+ Slides, Coatings 0884 amd 0885 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Ortho-Clinical Diagnostics 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
    15699
  • 사례 시작날짜
    2013-11-22
  • 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: Ortho-Clinical Diagnostics c/- Johnson & Johnson, 13A Gabador Place, Mt Wellington, AUCKLAND 1060
  • 원인
    Ortho clinical diagnostics (ocd) determined that vitros® chemistry products k+ slides, coatings 0884 and 0885 contain a surfactant that was unintentionally added during the manufacturing process. ocd has conducted testing that indicates that vitros® k+ slides made from coatings 0884 and 0885 are currently meeting their intended use and performance specifications. however, at this time we are unable to determine the effect that the addition of the surfactant may have on long-term product performance.
  • 조치
    Product to be destroyed

Device

Vitros Chemistry products K+ Slides, Coatings 0884 amd 0885

Manufacturer

Ortho-Clinical Diagnostics Inc