UREARecalls & reported problems across all models
Randox Laboratories Limited · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one UREA model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 3 models of UREA by Randox Laboratories Limited in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
UREA recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 3 of these models · Recall details · FDA record ↗
UREA models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- UREA UR3825Urease And Glutamic Dehydrogenase, Urea Nitrogen1 recall0 reports
- UREA UR3873Urease And Glutamic Dehydrogenase, Urea Nitrogen1 recall0 reports
- UREA UR8334Urease And Glutamic Dehydrogenase, Urea Nitrogen1 recall0 reports
Other Randox Laboratories Limited products
All Randox Laboratories Limited devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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