AQURE basic sytem — Class II medical device recall Z-0864-2020
Terminated recall by Radiometer Medical ApS, reported 2020-02-05, distributed nationwide. The firm has become aware that there is a potential problem relating to the blood gas and immunoassay analyzer
| Recall number | Z-0864-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer Medical ApS, Bronshoj, N/A, Denmark |
| Recall initiated | 2019-08-08 |
| Classified | 2020-01-24 |
| Reported by FDA | 2020-02-05 |
| Terminated | 2022-06-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, HU, IN, IT, JP, KR, NL, NO, PL, SE, SG, TR |
| Quantity | 947 |
| UPC / GTIN / UDI-DI | 05700699335999 |
| Model numbers | 933-599 |
Product
AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles.
Reason for recall
The firm has become aware that there is a potential problem relating to the blood gas and immunoassay analyzer Systems that may result in patient mix-up when connected to some third-party devices. The error may lead to serious adverse health consequences for the patient caused by patient data mix-up.
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-0864-2020. 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.