Events

Alerta De Seguridad para CELL DYN 4000 WBC Reagent Part AN ° List: 01 H77-01 Lot No: 18087-12 or higher.

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
    788
  • Fecha
    2004-08-13
  • 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
    Any questions regarding the information contained in this release, please call the Customer Service Center, Tel 0800-11-9099- Abbott Diagnostics Division. This Product Information has been developed by the Abbott Diagnostics Division to inform you of the change in the CELL DYN® 4000 WBC Reagent Part ANA list: 01H77-01.
  • Causa
    The abbott diagnostics division has adopted a new supplier of saponin, used in the cell dyn® 4000 wbc reagent part a. tests have indicated that the new formulation, with the new supplier of saponin (used to lyse the red blood cells), can generate a slight increase in flag rrbc (resistant red blood cell). a total of 119 samples, including 68 abnormal samples, were tested with the following results: · 2 samples with rrbc flag, with the current formulation (lower than batch no. 18087-12) · 5 samples with rrbc flag, with new formulation ( above the lot # 18087-12). you may notice a slight increase in the rrbc (resistant red blood cell) flag for lot # 18087-12 or higher.
  • Acción
    File this release in the CELL DYN® 4000 Operator's Manual, and fill out the Response Protocol and send via fax Fax: 0XX 11 - 5536 7181

Device

CELL DYN 4000 WBC Reagent Part AN ° List: 01 H77-01 Lot No: 18087-12 or higher.

Manufacturer

Abbott Laboratórios do Brasil Ltda
  • Source
    ANVSANVISA