FDA Device recall Z-1394-2023
AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devices and ope…
- FDA Device
- Class II
- ongoing
- Published 2023-04-26
On 2023-04-26 the FDA classified a Class II recall of AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devices and ope… by Radiometer Medical Aps, citing due to potential software issue that may result in patient mix-up information.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1394-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-08 |
| Published | 2023-04-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Radiometer Medical Aps |
| Distribution | US |
Product
AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage 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 you 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
Due to potential software issue that may result in patient mix-up information.
Identifiers
| code_info | Model Number: 933-599 UDI-DI Code: 05700699335999 Software Versions: 2.5.2 and above (Versions 2.5.2, 2.5.3, 2.5.4, 2.60, and 2.6.1) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1394-2023%22
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