Events

Alerta De Seguridad para ALCYON HDL, ANVISA Registration No. 10055310869, LIST 8D42-02, LOTES 85124HW00, 89031HW00 and 92010HW00

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por ABBOTT LABORATÓRIOS DO BRASIL LTDA.

¿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
    744
  • Fecha
    2003-06-06
  • 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
    Check if there are any batches in your stock. If you do, please contact ABBOTT LABORATORIOS DO BRASIL LTDA, by calling 0800-119099 or your local representative, in order to make the return and consequently the replacement of the same. The UTVIG - Technovigilance Unit is monitoring the entire collection, return and replacement process until it closes.
  • Causa
    They may deteriorate before the expiration date. the degradation of the reagent is indicated by the inability to produce acceptable calibrations and / or to recover controls within acceptable limits. in addition, linearity samples in the linearity range of the 180 mg / dl assay may not meet acceptable criteria. if calibrations and controls are within limits, patient outcomes were not affected for the batch numbers mentioned.
  • Acción
    Identify whether you are currently using or own stock of the ALCYON HDL Direct Reagent, lots 85124HW00,89031HW00 and 92010HW00 discontinue and store in your lab for later return.

Device

ALCYON HDL, ANVISA Registration No. 10055310869, LIST 8D42-02, LOTES 85124HW00, 89031HW00 and 920...

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA
  • Source
    ANVSANVISA