PlainRecalls
FDA Devices Moderate Class II Terminated

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 use

Reported: May 9, 2018 Initiated: February 27, 2018 #Z-1582-2018

Product 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.

Reason for Recall

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.

Details

Recalling Firm
Radiometer Medical ApS
Units Affected
2
Distribution
US Nationwide Distribution in the states to Georgia and Wisconsin.
Location
Bronshoj, N/A

Frequently Asked Questions

What product 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.. Recalled by Radiometer Medical ApS. Units affected: 2.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 9, 2018. Severity: Moderate. Recall number: Z-1582-2018.

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