Radiometer Medical ApS recalls AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of anal…

Recall date

February 27, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1582-2018

FDA classification

Class II

Brand / firm

Radiometer Medical ApS

Sold / distributed

US Nationwide Distribution in the states to Georgia and Wisconsin.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.