Siemens Healthcare Diagnostics, Inc.: Radioimmunoassay, Tricyclic Antidepressant Drugs
Siemens Healthcare Diagnostics is recalling Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls (Lot U2) used in clinical laboratories because the sodium azide preservative concentration is higher than specified, though test results were not affected. The risk to lab technicians is low, with potential exposure limited to mild skin or eye irritation. The product was distributed nationwide in the US, Canada, and several other countries.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-26
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/91fd9c4e-dce2-4574-bcee-1ddcd4b46903