Events

Alerta De Seguridad para CHEMICAL SYSTEM VITROS 4600 (Reg 80145900827) / CHEMICAL SYSTEM VITROS 5,1 FUSION (Reg 80145900827). Hazard Class: I. Products Affected: All VITROS® 4600 Diagnostic Systems with softaware version 3.2 and earlier and all VITROS® 5.1 Fusion Diagnostic Systems with software version 2.8 and earlier. List of affected SNs distributed in Brazil are in Annex I of this notification.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.; 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
    1772
  • Fecha
    2015-12-18
  • 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
    Considering the reduced likelihood that the anomaly will occur (<1 in 14 million), it is possible for the VITROS® 4600 and 5.1 FS Systems to process samples outside the appropriate temperature range where results will not be indicated with a result code of "IT" (incubator temperature).
  • Causa
    Ortho clinical diagnostics (ortho) has recently identified that under very specific conditions the temperature in the microwell subsystem (included in other vitros® systems) may potentially be out of range and the system does not properly alert the operator. although it does not include a microwell subsystem, the vitros® 4600 and 5.1 fs systems use the same software as the other vitros® systems. ortho has estimated that there is a 1 in 14 million lower incidence possibility that this anomaly might occur in the microslide or microtip subsystems included in the vitros® 5,1 fs systems, based on e-connectivity data.
  • Acción
    Recommendations to users and patients: Because of the reduced likelihood of this anomaly occurring, Ortho is not requiring the temperature of its system to be monitored. However, the customer may choose to check that his system is within the appropriate temperature range. Field Action Code: 15000167

Device

CHEMICAL SYSTEM VITROS 4600 (Reg 80145900827) / CHEMICAL SYSTEM VITROS 5,1 FUSION (Reg 8014590082...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.; ORTHO CLINICAL DIAGNOSTICS, INC