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.
Enforcement
- Recall Number
- Z-1582-2018
- Event ID
- 79411
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Radiometer Medical ApS
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 9, 2018
- Initiation Date
- February 27, 2018
- Classification Date
- May 1, 2018
- Termination Date
- March 20, 2019
- Address
- Akandevej 21, N/A, Bronshoj, N/A, N/A, Denmark
Description
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.
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.
Version 2.3.0 and 2.3.1
US Nationwide Distribution in the states to Georgia and Wisconsin.
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