Events

Notificaciones De Seguridad De Campo acerca de ID-DiaCell

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Bio-Rad Laboratories.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2017-09-27
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    We have been made aware that the above-mentioned products of cells may show antibody of (antibody undetermined specificity) undetermined specificity (aus) in iat method which are not confirmed by further testing's. the company is fully aware of the magnitude of this problem and the level of distress that this is causing in the field. a risk assessment has been performed and no patient risk has been identified. a team of experts is currently working on this issue äs an absolute priority. we will let you know about any updates of this issue.

Device

ID-DiaCell
  • Modelo / Serial
    ID-DiaCell 1-11-111 ID-DiaCell A1A2B/I-II-III ID-DiaCell 1-11 ID-DiaCell 1-11-111 Asia ID-DiaPanel ID-DiaPanel 6 Plus Cat. ref. n° 004310 003618 003613 003614 004114 004414
  • Manufacturer
    Bio-Rad Laboratories

Manufacturer

Bio-Rad Laboratories