AQURE REF 933-599 Software Versions 2 — Class II medical device recall Z-1394-2023
Ongoing recall by Radiometer Medical ApS, reported 2023-04-26, distributed nationwide. Due to potential software issue that may result in patient mix-up information.
| Recall number | Z-1394-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer Medical ApS, Bronshoj, N/A, Denmark |
| Recall initiated | 2023-03-08 |
| Classified | 2023-04-17 |
| Reported by FDA | 2023-04-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BH, BR, CH, CL, CN, CZ, DE, DK, ES, FI, FR, GB, GR, HK, HR, HU, IL, IN, IQ, IT, JO, JP, KR, KW, LB, LT, MX, MY, NL, NO, NZ, OM, PE, PL, PT, PY, QA, SA, SE, SG, TH, TR, UY, ZA |
| Quantity | 1,806 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 05700699335999 |
| Model numbers | 933-599 |
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 for recall
Due to potential software issue that may result in patient mix-up information.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1394-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.