Recall Z-1582-2018— Radiometer Medical ApS
Class II · Terminated
Class II FDA medical device recall by Radiometer Medical ApS, initiated 2018-02-27, terminated 2019-03-20. It names 3 FDA 510(k) clearances: K151856, K142898, K130144. 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.. 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
- Radiometer Medical ApS
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-02-27
- Terminated
- 2019-03-20
- Firm location
- Bronshoj, N/A, Denmark
510(k) clearances named in this recall
3 on FDA's record- K151856 — ABL80 FLEX CO-OX with AQURE connectivity
- K142898 — ABL800 FLEX with AQURE connectivity
- K130144 — ABL90 FLEX
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.