Recall Z-2881-2026
Siemens Healthcare Diagnostics, Inc. · initiated June 26, 2026
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
Codes / lots: UDI-DI 00842768014321 Lot U2
Reason for recall
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.
FDA-determined cause: Under Investigation by firm
Action taken
On June 26, 2026, the firm began notifying customers via Urgent Medical Device Correction letters. Customers were informed of the issue and provided with revised Safety Data Sheets (SDS) specific to the impacted lots for handling and disposal information.
Details
- Recall number
- Z-2881-2026
- Initiated
- June 26, 2026
- Posted by FDA
- August 4, 2026
- Product code
- LFG – Radioimmunoassay, Tricyclic Antidepressant Drugs
- Quantity
- 494 US; 114 OUS
- 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.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., East Walpole, MA