Events

PhoenixSpec Calibrator Kit 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 BD 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
  • 날짜
    2005-12-22
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-du-dmdiv-bd-phoenixspec-calibrator-kit-bd-diagnostics
  • 비고 / 경고
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • 데이터 추가 비고
  • 조치
    On 20/12/2005, the company BD Diagnostics has withdrawn lots 5075281 and 5115146 from the in vitro diagnostic medical device called BD PhoenixSpec Calibrator Kit reference 440911. This device is used for the calibration of the BD PhoenixSpec Nephelometer which allows the measurement turbidity of microbial suspensions equivalent to McFarland standards 0.10-4.50. This decision follows the detection of a problem of stability drift of the 0.25 MacFarland calibration tube contained in the aforementioned kits that could lead to a bad calibration of the device BD PhoenixSpec Nephelometer identified by an error message "CAL?" In addition, the manufacturer also reports that the Nephelometer Operator's Manual will be changed to the "CAL?" Error message. The company has directly notified the recipients of the incriminated lots by means of the message attached (20/12/2005) (16 KB) validated by Afssaps. The competent European authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

PhoenixSpec Calibrator Kit
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    BD Diagnostics

Manufacturer

BD Diagnostics