LowFDAOngoing
Unlikely to cause harm, but it breaks the rules.
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Check the device or its packaging for
UDI-DI 00842768001406 Lot U1
- Why
- 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.
- Distributed
- Worldwide - US Nationwide distribution in the states of CA and VA. The country of Japan.
- Company
- Siemens Healthcare Diagnostics, Inc.
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2880-2026 · retrieved 4 August 2026
Read the official notice