Recall Z-1582-2018 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Radiometer Medical ApS
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 comm
| Date | Mar 14, 2018 (initiated Feb 27, 2018) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 2 |
| Distribution | US Nationwide Distribution in the states to Georgia and Wisconsin. |
| FDA record | Open on fda.gov |