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CAROLINA LIQUID CHEMISTRIES CORP.® BUN RGT. KIT BL-252
CAROLINA LIQUID CHEMISTRIES CORPORATION · Model BL252 · UDI-DI 00817302020366
CDQ
Prescription
10
510(k) clearances
345
Adverse events
6
Recalls
37
Facilities
Description
BUN (Blood Urea Nitrogen) 3 x 170 tests
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.