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ONLINE TDM Lidocaine
Roche Diagnostics GmbH · Model 3376222190 · UDI-DI 04015630996933
KLR
Prescription
10
510(k) clearances
2
Adverse events
1
Recalls
5
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-26 | Siemens Healthcare Diagnostics, Inc. | Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk t |
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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.