Events

Alerta De Seguridad para CELL - DYN 26 CONTROL. Nº LIST 1H71-01 - Lot No: CD013

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
    714
  • Fecha
    2003-02-28
  • 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
    - Use the revised protocol (No. 9155136E) for product CELL DYN Control 26, lot CD013 and enter the correct value for HCT (all levels), MCH (low level) and MCHC (low level) in the System Quality Control file CELL-DYN 3200 following the instructions in the CELL DYN 3200 Operator's Manual, section 5. - Disregard the protocol prior to no. 9155136E of the CELL DYN product Control 26 above for lot CD013 - If you have established your own measures and ranges for lot CD013 , and inserted them into the Quality Control files of the Cell Dyn 3200 instrument, disregard the protocol of the CELL DYN Control 26 product. For more information, contact the Customer Service Center at 0800-119099.
  • Causa
    The abbott laboratories - diagnostics division reports a review of the parameters of hct (all 3 levels), mch (low level only) and mchc (low level only) for the cell-dyn control 26, lot cd013, only for the cell- dyn 3200.
  • Acción
    The Abbott Laboratories - Diagnostics Division, revised the values ​​of the CELL-DYN Control 26 protocol, lot CD013, for the CELL-DYN 3200 System only and updated the values ​​for the HCT (all 3 levels), MCH low) and MCHC (low level only).

Device

CELL - DYN 26 CONTROL. Nº LIST 1H71-01 - Lot No: CD013

Manufacturer

Abbott Laboratórios do Brasil Ltda
  • Source
    ANVSANVISA