United StatesSyva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls (Catalog No. 7C219UL, UDI‑DI 00842768014321), Lot U2, is being recalled. The lot has an out‑of‑specification sodium azide concentration; assay results were not impacted and the overall health risk to lab technicians is low (exposure limited by small volumes and a 0.2% post‑reconstitution sodium azide), with the worst outcome being mild skin or eye irritation and no serious harm anticipated.
What's being recalled
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
Recalling firm: Siemens Healthcare Diagnostics, Inc., East Walpole, MA, United States.
How to identify it
UDI-DI 00842768014321 Lot U2
The hazard
out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. 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 CA, ID, IL, IN, MA, MS, NC, NM, NY, OH, OK, OR, PA, WA, and Northern Mariana Islands part of USA and the countries of Canada, South Africa, Brazil, Chile, Colombia.
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)