Recall Z-1582-2018
Radiometer Medical ApS · initiated February 27, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Version 2.3.0 and 2.3.1
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-1582-2018
- Initiated
- February 27, 2018
- Posted by FDA
- March 14, 2018
- Terminated
- March 20, 2019
- Product code
- CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Quantity
- 2
- Distribution
- US Nationwide Distribution in the states to Georgia and Wisconsin.
- Recalling firm
- Radiometer Medical ApS, Bronshoj