Siemens Healthcare Diagnostics, Inc. recalls Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390

Recalling company

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 III – not likely to cause adverse health consequences

Recall date

Jun 26, 2026

Reported

Aug 12, 2026

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.

Status

Ongoing

Quantity

494 US; 114 OUS

Lot / codes

UDI-DI 00842768014321 Lot U2

Company location

East Walpole, MA

Recall type

Voluntary: Firm initiated

Recall number

Z-2881-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2881-2026 in the FDA Enforcement Report. Also see FDA recall press releases.