United StatesSyva Emit Disopyramide Assay Enzyme Immunoassay (Lidocaine SMN 10445370, Catalog No. 6N319UL, Lot U1, UDI‑DI 00842768001406) distributed worldwide including the U.S. (CA, VA) and Japan is affected. The calibrator in Lot U1 has an out‑of‑specification sodium azide concentration; assay results were not impacted, and the overall health risk to lab technicians is low with possible mild skin or eye irritation and no serious harm anticipated.
What's being recalled
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Recalling firm: Siemens Healthcare Diagnostics, Inc., Newark, DE, United States.
How to identify it
UDI-DI 00842768001406 Lot U1
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - US Nationwide distribution in the states of CA and VA. The country of Japan.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)