Events

Alerta De Seguridad para CHEMICAL SYSTEM VITROS 5,1 FUSION, Registration no. 80145900827, lots: See Annex 1 - Distribution list.

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
    1573
  • Fecha
    2015-05-04
  • 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 informs that if this anomaly occurs, it is possible that the VITROS® 5,1 FS System processes samples with a cartridge other than the intended cartridge, leading to potential erroneous patient results.
  • Causa
    Ortho-clinical diagnostics, inc. (ocd) has confirmed two cases in which the vitros® microslide cartridge has not been correctly identified. both cases occurred when an operator accessed slide supply 1 (ss1) before the green indicator light came on and then continued loading a dry reaction cartridge into slide supply 2. in both cases, the cartridge loaded in slide supply 2 was not correctly identified.
  • Acción
    The solution to this anomaly will appear in the next version of software currently under development. We'll issue a follow-up notification as soon as the software is available. In the meantime, if an operator inadvertently accesses a Slide Supply loading port before the green indicator light comes on and the system generates a TAS-70E or TAS-20E condition code (SLIDE SUPPLY 1 is OPEN or the SLIDE PORT SUPPLY 2 is OPEN), the operator must open and close the two Slide Supply ports (Slide Supply No. 1 and 2), remove or load cartridges, and initialize the system. This will cause the system software to scan all slots on the two Slide Supplies to correctly identify the contents.

Device

CHEMICAL SYSTEM VITROS 5,1 FUSION, Registration no. 80145900827, lots: See Annex 1 - Distribution...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho-Clinical Diagnostics, Inc.