FDA recall, , Low risk
Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls have out-of-specification sodium azide concentration, causing low health risk.
Summary by Recall Canary from the FDA notice
What happened
Siemens Healthcare Diagnostics, Inc., of East Walpole, Massachusetts, began a recall on June 26, 2026, of Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL because of an out-of-specification sodium azide concentration.
The FDA added the recall to its Enforcement Report on August 4, 2026, and included it in the weekly enforcement report on August 12, 2026. While assay results were not impacted, the health risk to lab technicians is low, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.
The product was distributed nationwide in the United States, including California, Idaho, Illinois, Indiana, Massachusetts, Mississippi, North Carolina, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Washington, and the Northern Mariana Islands, and to Canada, South Africa, Brazil, Chile, and Colombia.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
A UDI-DI is the device identifier printed with the barcode on the device label.
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls
- UDI-DI
- 00842768014321
- Lot code
- U2
From the FDA notice
Catalog No. 7C219UL
Recall details
- Company began the recall
- Sold in
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.
- Company
- Siemens Healthcare Diagnostics, Inc.East Walpole, Massachusetts
- Hazard
- Quality testing problem
- Risk
Low risk
Using it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 99381
- Recall number
- Z-2881-2026
- Quantity recalled
- 494 US; 114 OUS
All recalls from Siemens Healthcare Diagnostics, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
