Events

Alerta De Seguridad para ADVIA Chemistry XPT Technical Name: ADVIA Chemistry XPT ANVISA Registration Number: 10345161947 Hazard Class: I Affected Model: ADVIA Chemistry XPT Affected Batch / Series Numbers: 10345161947

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Healthcare Diagnósticos S.A; Siemens Shenzhen Magnetic Resonance Ltd..

¿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
    2092
  • Fecha
    2016-08-19
  • 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
    Siemens recommends only in cases where the laboratory uses ADVIA Chemistry Hemoglobin A1c_3 Automatic Pre-treatment (A1c_3) on ADVIA XPT and reports results in IFCC units (mmol / mol), discontinue the release of these results. Or that repeat samples of patients with less than 35 mmol / mol that have been generated in the last 4 months, under the same conditions mentioned above, should be performed.
  • Causa
    Siemens healthcare diagnostics has identified a problem with the ratio of the equation provided on the advia chemistry xpt version 1.0 test definition software (tdef) disks. this problem only affects the results of advia chemistry hemoglobin a1c_3 automatic pretreatment (a1c_3) when hba1c values ​​are reported in the equivalent units of the ifcc.
  • Acción
    Field Action Code CHSW 16-02 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will send Letter to the Client.

Device

ADVIA Chemistry XPT Technical Name: ADVIA Chemistry XPT ANVISA Registration Number: 10345161947 H...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens Shenzhen Magnetic Resonance Ltd.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA