Events

Alerta De Seguridad para ADVIA Chemistry ALP (AMP) Reagents - Registration No. 10345160518. Lots: R1: 7X38mL - R2: 7X11,7mL (7 x 357 tests); R1: 4X38 mL-R2: 3X15mL (4 x 350 tests). Lots: 327460

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..

¿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
    1701
  • Fecha
    2015-10-21
  • 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 has identified that the increase in the incidence of absorbance flags associated with lots of reagents is not related to inaccurate results. If results of calibrations and quality controls are acceptable, reported patient outcomes are also acceptable.
  • Causa
    Siemens healthcare has confirmed that the alkaline phosphatase reagents contained in the portuguese letter chc 15-16 (alert message) used in the advia chemistry 1200, 1800, 2400 and xpt systems have shown an increase in the incidence of flags (u and u) and errors // //. the absorbance flags u and u indicate high absorbance, exceeding the boundary values ​​defined in the test protocol for blank or sample limits. the absorbance flags //// indicate an error in the calculation, not allowing the generation of results by the system.
  • Acción
    Siemens Healthcare recommends the following actions: - Discontinue use and discard batches of reagents identified in this Field Action; - Keep the Portuguese Letter CHC 15-16 (Alert Message) in your laboratory records for any future consultations.

Device

ADVIA Chemistry ALP (AMP) Reagents - Registration No. 10345160518. Lots: R1: 7X38mL - R2: 7X11,7m...

Manufacturer

Siemens Healthcare Diagnósticos S.A.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA