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BUN
RANDOX LABORATORIES LIMITED · Model UR2821 · UDI-DI 05055273206890
CDQ
Prescription
1
510(k) clearances
347
Adverse events
6
Recalls
39
Facilities
Description
The BUN method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of urea nitrogen in serum, plasma and urine.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-08-08 | Siemens Healthcare Diagnostics, Inc. | 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 wil |
| 2023-06-13 | Randox Laboratories Ltd. | 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 t |
| 2018-03-27 | Siemens Healthcare Diagnostics, Inc. | Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails. |
| 2016-02-16 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has determined that Dimension Vista Blood Urea Nitrogen (BUN) lots 15215AE, 15243BB, 15264BA, 15299BB, 15300BA and 15341AC may exhibit inaccurate pat |
| 2011-10-03 | Abbott Laboratories, Inc | 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. |
| 2003-11-24 | Abbott Laboratories Diagnostic Div | False low results may occur with out error codes due to substrate depletion in samples with more than 220mg/dL BUN. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.