FDAFDA · Alimentos y medicamentos·N.º oficial Z-1582-2018
AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets the user send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use.
Publicado el 9 de mayo de 2018 · Inicio del retiro: 27 de febrero de 2018
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
There is a potential problem relating to the AQURE System, versions 2.3.0 and 2.3.1, that may result in patient mix-up.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Radiometer Medical ApS
- Distribuidor
- US Nationwide Distribution in the states to Georgia and Wisconsin.
- Lote
- Version 2.3.0 and 2.3.1
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Denmark
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.