Urease And Glutamic Dehydrogenase, Urea Nitrogen
FDA adverse event reports and recall history for urease and glutamic dehydrogenase, urea nitrogen (product code CDQ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 344
- Deaths
- 0
- Injuries
- 0
- Malfunctions
- 340
Reports per year
Source: FDA adverse event reports by year received, 2010–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2023-09-30Open, ClassifiedUnder Investigation by firm
ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)
There is a potential for a positive bias on Quality Control (QC) and patient sample results when using some IRON_2 reagent wedge pairs. When the issue occurs, the observed bias will vary wedge to wedge.
- 2023-08-09Open, ClassifiedUnder Investigation by firm
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
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.
- 2011-11-16TerminatedProcess control
Clinical Chemistry Urea Nitrogen List Number 7D75-21 and 7D75-31 used for the Quantitation of urea nitrogen in human serum, plasma, and urine.
The reagents are being recalled due to particulate matter in some of the reagent cartridges. The particulate matter has been identified as Aureobasidium fungus species.
- 2003-12-18TerminatedOther
AEROSET/ARCHITECT c8000 Urea Nitrogen Models: 7D75-01; 7D75-20; 7D75-30
False low results may occur with out error codes due to substrate depletion in samples with more than 220mg/dL BUN.
- TerminatedNonconforming Material/Component
Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative measurement of urea nitrogen (an end product of nitrogen metabolism) in human serum, plasma, and urine on the Dimension Vista System.
Siemens Healthcare Diagnostics has determined that Dimension Vista Blood Urea Nitrogen (BUN) lots 15215AE, 15243BB, 15264BA, 15299BB, 15300BA and 15341AC may exhibit inaccurate patient and/or Quality Control results. The issue has been isolated to Flex reagen cartridges manufactured from specific mold cavities.
- TerminatedMaterial/Component Contamination
ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails.
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