Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 ... recall (Siemens Healthcare Diagnostics, Inc.)
Medical deviceClass IIIOngoing
Summary: Siemens Healthcare Diagnostics, Inc. is recalling Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL. Reason: 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 is being recalled
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
Why
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.
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
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. (states named: California, Idaho, Illinois, Indiana, Massachusetts, Mississippi, North Carolina, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Washington)
How to tell if yours is affected
UDI-DI 00842768014321 Lot U2
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2881-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | June 26, 2026 |
| Reported | August 12, 2026 |
| Company | Siemens Healthcare Diagnostics, Inc. |
| Company location | East Walpole, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 494 US; 114 OUS |
More recalls from Siemens Healthcare Diagnostics, Inc. · all medical device recalls · recalls from June 2026