Alerta De Seguridad para TOTAL PROTEIN - Record in Anvisa - 80115310073 - Lots Affected: 1073671330/1073671229/1073661354/1073661352/1073661353/1085501210/1085501211/1073661249/1073671227/1073661251/1085501313/1073671228.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por KOVALENT 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
    1238
  • Fecha
    2013-04-02
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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 loss of stability in the on-board situation is being investigated. Additional control measures will be defined. The risk of releasing incorrect results is considered medium to high if the instructions for use of the product are not followed. As the instructions for use are emphatic regarding the need for use of controls during the procedure, the remaining probability of incorrect results becomes low and the risk tolerable. The controls used will detect the need for re-calibration of the test before releasing the final results. In the manual procedure this loss of stability is not observed since, after use, the reagent bottles are capped and returned to the storage informed in the Instructions for Use.
  • Causa
    Loss of stability of the reagents after a few hours when in the "on board" situation, ie when left inside the rotor of automated equipment.
  • Acción
    The company recommends that the use of the products be stopped immediately. Verify in your inventory the existence of the lot of the affected product, segregating it and returning it or destroying it, according to the institution's procedures and those recommended by the manufacturer.

Manufacturer