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GENCHEM™ Electrode, Ion Specific, Urea Nitrogen (BUN) reagent
GENCHEM INC · Model GEN-BUN3 · UDI-DI 00851445007075
CDS
Prescription
10
510(k) clearances
7
Adverse events
1
Recalls
13
Facilities
Description
10/17/2022
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-10-31 | Roche Diagnostics Operations, Inc. | Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and cannot be detected by QC. QC measurement results can be affected as well. This issue |
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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.