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Urease And Glutamic Dehydrogenase, Urea Nitrogen
FDA product code CDQ · Class 2 · Clinical Chemistry
108
Registered devices
347
Adverse events
6
Recalls
117
510(k) clearances
Devices with this code
Teco Diagnostics TC Matrix Clinical Chemistry Analyzer — TECO DIAGNOSTICSJAS Diagnostics — DREW SCIENTIFIC, INC.IDG/Sanzay — IDG/SANZAY CorporationUREA — RANDOX LABORATORIES LIMITEDAU — Beckman Coulter, Inc.Synermed® — INFRARED LABORATORY SYSTEMS LLCUREA — RANDOX LABORATORIES LIMITEDSynermed® — INFRARED LABORATORY SYSTEMS LLCDimension® Flex® reagent cartridge BUN — Siemens Healthcare Diagnostics Inc.Sirrus® Urea Nitrigen (BUN) Liqui-UV® — STANBIO LABORATORY, L.P.CAROLINA LIQUID CHEMISTRIES CORP.® BUN RGT. KIT AU-252 — CAROLINA LIQUID CHEMISTRIES CORPORATIONBUN/BS200 — Medtest Dx, Inc.Pointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDBUN/BS480 — Medtest Dx, Inc.Pointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDABX PENTRA UREA CP — HORIBA ABX SASJAS Diagnostics — DREW SCIENTIFIC, INC.AU — Beckman Coulter, Inc.Pointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDSynermed® — INFRARED LABORATORY SYSTEMS LLCUREA — RANDOX LABORATORIES LIMITEDBun Rate Reagent — CLINIQA CORPORATIONTeco Diagnostics TC Matrix Clinical Chemistry Analyzer — TECO DIAGNOSTICSUREA — RANDOX LABORATORIES LIMITED
Recent 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, t |
| 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 |
| 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 ex |
| 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 |
| 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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