Events

Alerta De Seguridad para Data-Cyte Plus Day 0.8% Technical Name: ANTIBODIES / SYSTEMS FOR DIFFERENTIAL CELL COUNTING ANVISA Registration Number: 80134860207 Hazard Class: III Model Affected: Code 213627 Serial Numbers Affected: 611316015

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Medion Diagnostics Grifols.

¿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
    2061
  • Fecha
    2017-01-27
  • 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
    Discontinue use of the product and send / return affected panels to destruction. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Causa
    Through in-house tests, data-cyte plus day # 12 cell day 0.8%, lot: 611316015, validity 28-01-2017 has been identified that can react falsely positive with serum / plasma samples containing no unexpected antibodies. preliminary results from the internal investigation have shown that false positive results may be due to blood reagent cells or a combination of blood reagent cells and dg gel card. the equipment was excluded as a contributing factor because manual tests without the equipment confirmed the observations. the risk analysis has shown that there is no harm to the patient and that the remaining risk is exclusively reduced to a delay in transfusion but in no case can result in a wrong transfusion due to the interpretation of the test.
  • Acción
    Field Action Code 2017-01 triggered under the responsibility of the company Grifols Brasil Ltda. Company will collect for further destruction of the product.

Device

Data-Cyte Plus Day 0.8% Technical Name: ANTIBODIES / SYSTEMS FOR DIFFERENTIAL CELL COUNTING ANVIS...

Manufacturer

Medion Diagnostics Grifols
  • Empresa matriz del fabricante (2017)
    Grifols Sa
  • Source
    ANVSANVISA