Recall
FDAHealthJune 26, 2026

Siemens Healthcare Diagnostics, Inc. — Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL

⚠️ 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.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
June 26, 2026

Worldwide - US Nationwide distribution in the states of CA and VA. The country of Japan.

What's affected?

Product
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Lot code
U1

Additional details

UDI-DI 00842768001406 Lot U1

What should I do?

Recommended action

Class III recall. Voluntary: Firm initiated Quantity affected: 8 US; 44 OUS.

View original FDA notice →

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