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QMS Lidocaine Immunoassay

Microgenics Corporation · Model 0374686 · UDI-DI 00884883006072

KLR
1
510(k) clearances
2
Adverse events
1
Recalls
5
Facilities

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 overall health risk t

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Data 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.