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BUN Reagent
Diamond Diagnostics Inc. · Model BK-443350D · UDI-DI 00811403011124
CDS
Prescription
10
510(k) clearances
7
Adverse events
1
Recalls
13
Facilities
Description
For the quantitative determination of urea nitrogen in serum or plasma.
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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