Events

Alerta De Seguridad para Vitros Chemistry Systems: (1) Model 950, (2) Model 950AT. Series Nos .: (1) below 09501559, (2) below 09600129

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Ortho-Clinical Diagnostics Inc.

¿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
  • ID del evento
    223
  • Fecha
    2000-12-15
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    In the chemical systems described, an atypical pattern occurred in the relation between the millivolt slide used to calculate a predicted concentration and the reading of the millivolt slide used to evaluate the slide impedance. the manufacturer initiated a correction by mail dated february 28, 2000.
  • Acción
    Make sure you have received the correspondence sent on February 28, 2000, by Ortho-Clinical Diagnostics. Confirm that software version 2.04 or newer is installed on the systems described. Ortho-Clinical Diagnostics states that removal in the United States is now complete. No additional action is required by US service providers. International removal is in progress. Contact your local Ortho-Clinical Diagnostics representative or directly to the United States by mail at the address listed for more information on removal procedures.

Device

Vitros Chemistry Systems: (1) Model 950, (2) Model 950AT. Series Nos .: (1) below 09501559, (2) b...

Manufacturer

Ortho-Clinical Diagnostics Inc