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Enzyme Immunoassay, Lidocaine

FDA product code KLR · Class 2 · Clinical Toxicology

8
Registered devices
2
Adverse events
1
Recalls
17
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-06-26Siemens 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 o

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