Events

BD Multitest™ 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 Becton Dickinson France S.A.S. 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
    2017-07-28
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • 데이터 추가 비고
  • 원인
    Bd has recently confirmed that the instructions for use (ifu) part number 23-5351-03, dated 6/2016, for the reagent lots listed in the product tables below, contains errors in table 2: representative reference intervals for bd multitest™ cd3/cd8/cd45/cd4 listed on page 22. product performance is not impacted. table 1 below illustrates the values currently listed in the ifu and the correct values. .

Device

BD Multitest™
  • 모델명 / 제조번호(시리얼번호)
    BD Multitest™ CD3/CD8/CD45/CD4 342417 13532 2018-11-30 18636 2017-12-31 29783 2019-03-31 33552 2018-10-30 40550 2019-01-31 70946 2019-03-31 09831 2017-10-31 20936 2018-02-28 25555 2018-06-30 31761 2018-03-31 31864 2017-07-31 51629 2017-08-31 51897 2018-05-31 84976 2018-07-31 94769 2017-09-30 BD Multitest™ CD3/CD8/CD45/CD4 with BD Trucount™ Tubes 342447 11816 2019-03-31 11819 2019-03-31 35773 2019-04-30 35775 2019-04-30 63687 2019-05-31 70875 2019-02-28 03951 2017-08-31 09823 2017-09-30 20649 2018-07-31 23539 2018-11-30 25563 2018-05-31 26584 2018-06-30 27802 2017-10-31 29704 2017-12-31 29705 2017-12-31 33569 2018-09-30 34537 2017-12-31 38857 2017-07-31 38858 2017-07-31 38864 2017-07-31 42504 2017-07-31 42517 2018-09-30 43620 2018-07-31 45543 2018-02-28 50963 2018-07-31 53847 2017-12-31 53862 2017-12-31 55701 2018-02-28 57694 2018-07-31 60147 2017-10-31 60974 2017-10-31 61386 2018-03-31 71855 2017-08-31 81744 2018-03-31 81755 2018-03-31 81769 2017-12-31 87604 2018-07-31 87798 2017-08-31 90737 2017-12-31 93727 2018-03-31
  • Manufacturer
    Becton Dickinson France S.A.S.

Manufacturer

Becton Dickinson France S.A.S.