Company:Radiometer Medical ApS
Date of Enforcement Report 5/9/2018
Class lI:
PRODUCT
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.
Recall Number Z-1982-2018
REASON
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.
RECALLING FIRM/MANUFACTURER
FRadiometer Medical ApS, Bronshoj , Denmark on 2/27/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2
DISTRIBUTION
US Nationwide Distribution in the states to Georgia and Wisconsin.
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