Emit Disopyramide Assay

• • Ongoing Z-2880-2026 FDA Class III ·initiated 26 Jun 2026

  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 due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.

510(k) Number

K801204 ↗

FDA Product Code

KLR

Device Class

Class II

Regulation

21 CFR Part 862.3555

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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