FDA Device

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

Hazard

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.

What You Should Do

Remedy

Radiometer Medical sent a Notification letter dated February 27, 2018 to customers. The letter identified the affected product, problem and actions to be taken For questions contact your Radiometer representative.

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Products

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 t
Brand
Radiometer Medical ApS Akandevej 21 Bronshoj Denmark
UPC
Version 2.3.0 and 2.3.1

Units Affected

2

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