Events

Elecsys Vitamin D total II and Vitamin D total II 에 대한 현장 안전성 서한

Inspectie Gezondheidszorg en Jeugd에 따르면, 해당 현장 안전성 서한 는 Netherlands 에서 Roche Diagnostics GmbH 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 날짜
    2018-05-03
  • 사례 국가
    Netherlands
  • 사례 출처
    IGJ
  • 사례 출처 URL
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2018/05/03/roche-diagnostics-cn-355457---elecsys-vitamin-d-total-ii
  • 비고 / 경고
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • 데이터 추가 비고
  • 원인
    In this update, we would like to inform you that the issue occurs only with plasma samples and we provide you with an updated workaround. serum samples are not affected and can be measured without workaround. irrespective of the sample type, we would like to remind you of the importance of pre-analytical handling and sample quality when running elecsys vitamin d total ii. during the implementation of the elecsys vitamin d total ii assay on modular analytics e 170, cobas e 601 and cobas e 602 systems, customers reported non-reproducible, false high results.

Device

Elecsys Vitamin D total II and Vitamin D total II

Manufacturer

Roche Diagnostics GmbH
  • 제조사 모회사 (2017)
    Roche Holding Ag
  • 제조사 의견
    Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
  • Source
    IGJ