VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - ANALYZER CLASS-II 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
    52233
  • 사례 위험등급
    III
  • 사례 시작날짜
    2013-06-10
  • 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
    Ocd has announced a recall to inform customers of a change to the frequency of replacement for the cm/rt wear pads on vitros 5600 4600 and 51 fs systems. cm/rt wear pads are a component in the cm/rt incubator. the cm/rt rotor revolves on three wear pads within the incubator. by design there is a small gap between the rotor and the hot plate to allow for the transfer of heat. if the wear pads become too thin it may cause the rotor to rub on the hot plate resulting in black dust within the incubator. the impact of black dust may contribute to unplanned system down time. we have no data that suggests that black dust has any adverse effect on results.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 6801375 (Lot serial: > 10 contact manufacturer); Model Catalog: 6802413 (Lot serial: > 10 contact manufacturer); Model Catalog: 680 2413 (Lot serial: > 10 contact manufacturer); Model Catalog: 6801890 (Lot serial: > 10 contact manufacturer); Model Catalog: 680 2445 (Lot serial: > 10 contact manufacturer)
  • 제품 설명
    VITROS 51 FS Chemistry System
  • Manufacturer

Manufacturer