Urea/Bun 08058806190Recalls & reported problems
Roche Diagnostics GmbH · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613336121603), received between Aug 11, 2026 and Aug 11, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Non Reproducible Results” (1 report).
1 other recall cover devices cleared under the same FDA submission (K972250); they may or may not involve this specific model.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Non Reproducible Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2026Non Reproducible Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50212987 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K972250. One submission often covers many models, so check the product and lot details in each record.
- Z-0688-2008 · Dec 3, 2007 · TerminatedRoche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322. Roche Diagnostics Corp., Indianapolis, IN 46250
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 UR3825Randox Laboratories Limited · 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
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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