Siemens Syva Emit tox calibrator/controls recalled for sodium azide level
Siemens Healthcare Diagnostics recalled Lot U2 of its Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls because the sodium azide concentration is outside specifications. The company says assay results were not affected, and the health risk to lab technicians is low, with the worst expected outcome being mild skin or eye irritation.
From the FDA notice · Read the official notice ↗ · All Siemens recalls
What to do
- Check whether your lab has Lot U2 of catalog number 7C219UL.
- Contact Siemens Healthcare Diagnostics for guidance on affected material.
- Follow your laboratory's procedures for handling and disposing of recalled reagents.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 494 US; 114 OUS
- Illnesses reported
- None reported
- Manufactured in
- 333 Coney St, East Walpole, MA, United States
- Classification
- Class III
- Recall number
- Z-2881-2026
In the FDA's words
- Description
- Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL 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. UDI-DI 00842768014321 Lot U2 Distribution: 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. Affected quantity: 494 US; 114 OUS
- 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.
More from Siemens
See all- Siemens Atellica CH HDL reagent recalled for possible false test results
ModerateFDANov 6, 2026
- Siemens Syva EMIT 2000 Quinidine Assay recalled for inaccurate test results
SeriousFDAAug 26, 2026
- Siemens Atellica CH Urine Albumin test recalled for false results
ModerateFDAAug 12, 2026