Events

Alerta De Seguridad para VITROS 5.1 FUSION Chemical System, Registration No. 80145900827 and VITROS 4600 and 5600 Chemical System, Registration No. 80145901335, lots / Serial No .: 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
    1587
  • Fecha
    2015-05-14
  • 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 for urine samples from patients who require pre-treatment, place each of the pre-treated sample types in a separate container. Manually program the individual samples. NOTE: A LIS download can be used to program urine samples only if tests that require sample pretreatment and tests that do not require pretreatment are not included in the same sample program. Place this notification on each VITROS® 4600, 5600, and 5.1FS System of your installation or together with the user documentation. Talk to your Lab Medical Director about any questions regarding previously reported results to determine the appropriate course of action.
  • Causa
    The company reported that ortho-clinical diagnostics, inc. (ocd) has confirmed cases for vitros® 5,1 fs (software version 2.8 and previous) and vitros® 4600 and 5600 systems (software version 3.2 and previous). that the vitros® system allowed urine specimens for testing requiring acidification pretreatment to be dosed from the same sample vessel as non-pretreatment tests when samples were programmed.
  • Acción
    The company informs that if this anomaly occurs, it is possible that the VITROS® 4600, 5600 and 5.1 FS Systems process urine samples without correct pretreatment, leading to potential outcomes of patients with bias. See attached table of communication with examples of biased results obtained during the research.

Device

VITROS 5.1 FUSION Chemical System, Registration No. 80145900827 and VITROS 4600 and 5600 Chemical...

Manufacturer

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