Events

Alerta De Seguridad para EnGen ™ Laboratory Automation System - TCA, Registration no. 80145909053, lots / series: J3J4B45J.

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; Thermo Fisher Scientific Oy..

¿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
    1586
  • 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 reports that OCD internal tests have confirmed cases in which the VITROS® 5,1 FS, 4600 or 5600 Systems allowed the analysis of multiple tests using a single urine sample, regardless of the pretreatment requirements of each selected test, causing potentially outcomes of patients with bias.
  • Causa
    The company that owns the registry informs that urine samples for use with vitros® ca, mg and phos slides require acidification (pre-treatment). the engen ™ system software currently does not route these samples to the manual high priority exit site for pretreatment as indicated. in addition, the engen ™ system software currently allows for the provision of invalid test combinations, which include urine samples with different pre-treatment requirements. depending on the test, urine specimens need to be acidified, alkalized, extracted or untreated prior to being processed on vitros® systems.
  • Acción
    The company directs that the service does not request VITROS® Ca, Mg and PHOS Slide tests using urine samples with no other tests. Do not place urine samples for VITROS® Ca, Mg and PHOS Slide tests on the rail for sorting or routing. Place the pre-treated urine samples for these tests directly into the analyzer. Talk to your Lab Medical Director about any questions regarding previously reported results to determine the appropriate course of action.

Device

EnGen ™ Laboratory Automation System - TCA, Registration no. 80145909053, lots / series: J3J4B45J.

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Thermo Fisher Scientific Oy.
  • Source
    ANVSANVISA