# FDA device recall: Syva Emit Disopyramide Assay  Enzyme Immunoassay, Lidocaine  SMN 10445370  Catalog No 6N319UL

> recall · VERIFIED · 2026-06-26

Firm: Siemens Healthcare Diagnostics, Inc. · Class III · 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 to lab technicians du

- Company: Siemens Healthcare Diagnostics, Inc.
- Sector: diagnostics
- Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Source: MedFuel Intel news monitor. Verification tier: VERIFIED. Informational only, not investment advice. Corrections: media@medfuelinc.com.