Events

Alerta De Seguridad para IMx Kit B12 Reagent No. batch 75782M200

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 - Divisão Diagnósticos.

¿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
    711
  • Fecha
    2002-07-25
  • 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 investigation of this issue is under way. Abbott, is working to speed up the replacement of the IMx B12 reagent product No. batch 75782M200, so we recommend alternative methods for performing the test. For more information contact your local representative or directly with Abbott Laboratories of Brazil LTDA - Diagnostics Division (0xx11 ) - 5536.7000
  • Causa
    Studies with the reagent imx b12 assay no. batch 75782m200, performed by abbott laboratories, have demonstrated that calibration failure, non-limiting controls, and non-reproducibility of patient outcomes may occur.
  • Acción
    . Review the results of the controls for the reagent IMx B12 assay No. lot 75782M200. . Discontinue use of reagent IMx B12 batch No. 75782M200 verify that the results of the low control are out of range as recommended in the package insert. If the low control is off (above and below the limits for low control), it is recommended to retest patients with results inconsistent with the clinical evaluation made by the physician. If the low control is within the limits described in the package insert, no action of retesting the patient results is necessary. . No action is required for the Medium and High controls.

Device

IMx Kit B12 Reagent No. batch 75782M200

Manufacturer

Abbott Laboratórios do Brasil LTDA - Divisão Diagnósticos
  • Source
    ANVSANVISA