AQURE System — Class II medical device recall Z-0748-2016
Terminated recall by Radiometer America Inc, reported 2016-02-10, distributed nationwide. The AQURE System has a design error regarding sample type in which sample type may be specified for some resul
| Recall number | Z-0748-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer America Inc, Brea, CA, United States |
| Recall initiated | 2015-12-29 |
| Classified | 2016-02-03 |
| Reported by FDA | 2016-02-10 |
| Terminated | 2016-03-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CH, CN, CZ, DE, DK, EE, ES, FI, FR, GB, HK, IE, IT, JO, JP, KR, KW, MY, NL, NO, NZ, OM, PL, QA, RU, SA, SE, SG, TW, ZA |
| Quantity | 375 |
| Model numbers | 933-599 |
Product
AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.
Reason for recall
The AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results. The fact that the sample type field is left blank in some cases could lead to misinterpretation of results.
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-0748-2016. 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.