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NOVA BIOMEDICAL CORPORATION · Model 16 · UDI-DI 00385480175111
CDS
Prescription
1
510(k) clearances
7
Adverse events
1
Recalls
13
Facilities
Description
NOVA 16 BUN SENSOR
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.