Medical Device Recall: Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Siemens Healthcare Diagnostics, Inc. · June 26, 2026
Reason for Recall
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.
Distribution
Worldwide - US Nationwide distribution in the states of CA and VA. The country of Japan.
States Affected
NATIONWIDE
Quantity Affected
8 US; 44 OUS
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2880-2026
Status: ongoing
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