Siemens Healthcare Diagnostics, Inc. 2026-08-12 Health moderate FDA
Health · FDA · Recall #FDA-Z-2881-2026
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog… Recall
Issued August 12, 2026 · Siemens Healthcare Diagnostics, Inc.
In August 2026, Siemens Healthcare Diagnostics, Inc. recalled the Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog…, a moderate health recall reported by the FDA.
Compiled by Dana Whitfield, RecallCheckr
What this means for you
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 you should do
- 1 Stop using Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Siemens Healthcare Diagnostics, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Siemens Healthcare Diagnostics, Inc.
- Category
- Health
- Recall date
- August 12, 2026
- Units affected
- Not reported
- Sold at
- 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 pa
- Recall number
- FDA-Z-2881-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Siemens Healthcare Diagnostics, Inc. has 10 recalls in our database.
- We're tracking 3,707 Health recalls in our database.
- This is the 487th Health recall we've logged in 2026.