- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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.
- Affected products (lot / model / serial)
- UDI-DI 00842768014321 Lot U2
- Units affected
- 494 US; 114 OUS
- Distribution pattern
- 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.
- Firm location
- East Walpole, MA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2881-2026
- Recall initiated
- June 26, 2026
- FDA classification date
- August 4, 2026
- FDA report date
- August 12, 2026
- FDA event ID
- 99381
- Last updated on HTM Vibe
- August 18, 2026