Events

Alerta De Seguridad para VIDAS 3 system

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por BioMérieux.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2013-12-23
  • Fecha de publicación del evento
    2013-12-23
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131223.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: biomérieux vidas 3 system medical device manufacturer, biomérieux, has issued a medical device safety alert concerning its vidas 3 system [catalogue number: 412590]. the manufacturer was informed that some customers experienced pipetting issue on the instrument vidas 3 ref. 412590 when they use tubes with an external diameter of around 12 mm. the issue is due to a collision between a small flat step at the top of the tip and the tube edges when the pipettor is going down to aspirate in the tube. the instrument identifies the problem and errors 0956 xapu and/or 0502 (loading bay errors) happen. there is no risk to have an incorrect diagnostic because the error message will occur before having a diagnostic result. the manufacturer advises users to stop using the tubes size of 12 mm and to use tubes with a larger diameter (13 and/or 16 mm as per user manual) until corrective actions are implemented. the user manual will be updated based on the investigation results. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 december 2013.

Device

VIDAS 3 system
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: BioMérieux VIDAS 3 system
  • Manufacturer
    BioMérieux

Manufacturer

BioMérieux