Events

Alerta De Seguridad para Reflotron Uric Acid, Record: 10287410183, Lots: 20750002, 21149403, 21836402, 21625703, 21506202, 22222403, 22311502, 22500902, 22618503, 22915302, 23179404, 23336508

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH.

¿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
    1655
  • Fecha
    2015-07-30
  • 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
    The company reports that although erroneous uric acid results are not likely to lead to an immediate serious adverse event, a medical risk due to the low false uric acid results in samples with a hematocrit above 48% can not be ruled out.
  • Causa
    After internal evaluation, roche diagnostics gmbh decided to reduce the hematocrit limit value from 55% to a maximum of 48% for reflotron uric acid products for the measurement of whole patient blood samples. during an internal investigation the manufacturer detected deviations in uric acid results in the reflotron system, which may be above the internal specification of 5% if hematocrit values ​​exceed 48%. this may lead to erroneously low uric acid results in whole blood samples with hematocrit greater than 48%. currently hematocrit values ​​are up to 55% for reflotron uric acid.
  • Acción
    The company informs that a note will be added inside the Reflotron Uric Acid box informing about the reduction of the hematocrit limit value to a maximum of 48%. It further states that this information should be taken into account in measurements of whole blood samples from patients

Device

Reflotron Uric Acid, Record: 10287410183, Lots: 20750002, 21149403, 21836402, 21625703, 21506202,...

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH