VITROS CHEMISTRY PRODUCTS SYSTEM - K+ SLIDES (POTASSIUM) 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 ORTHO-CLINICAL DIAGNOSTICS 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
    59925
  • 사례 위험등급
    III
  • 사례 시작날짜
    2013-05-14
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    While performing an internal investigation ocd determined that vitros chemistry products k+ slides coatings 0884 and 0885 contain a surfactant that was unintentionally added during the manufacturing process. the surfactant is used in several vitros slide products but it is not included in the product specifications for vitros k+ slides. 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.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 8157596 (Lot serial: 410208850657); Model Catalog: 8157596 (Lot serial: 410208840049); Model Catalog: 8157596 (Lot serial: 410208850389)
  • 제품 설명
    VITROS Chemistry Products Potassium (K+) Slides
  • Manufacturer

Manufacturer