FDA Device recall Z-0748-2016
AQURE System
- FDA Device
- Class II
- terminated
- Published 2016-02-10
On 2016-02-10 the FDA classified a Class II recall of AQURE System by Radiometer America, citing 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 fi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0748-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-29 |
| Published | 2016-02-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Radiometer America |
| Distribution | US |
Product
AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.
Reason
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.
Identifiers
| code_info | Model Number: 933-599 Version 1.8.3 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0748-2016%22
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