UREA UR3825Recalls & reported problems
Randox Laboratories Limited · This product is intended for the quantitative in vitro determination of Urea in serum, plasma or urine. · Class 2
All models of UREA (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- Jun 13, 2023Open, Classified
Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples, in urea assays results if the urea assay is run immediately after the Direct LDL-cholesterol assay. This may lead to a delay in reporting results or in falsely decreased urea test results.
Z-2362-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other Urease And Glutamic Dehydrogenase, Urea Nitrogen devices
- ADVIA® Chemistry UN Urea Nitrogen Reagents 10309051Siemens Healthcare Diagnostics Inc. · UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN1 recall0 reports
- UREA UR3873Randox Laboratories Limited · Urease And Glutamic Dehydrogenase, Urea Nitrogen1 recall0 reports
- UREA UR8334Randox Laboratories Limited · Urease And Glutamic Dehydrogenase, Urea Nitrogen1 recall0 reports
- UreaBUN 5171873190Roche Diagnostics GmbH · UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN8 reports
- UreaBUN 4460715190Roche Diagnostics GmbH · UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN6 reports
- Urea/Bun 08058806190Roche Diagnostics GmbH · UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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