Siemens Healthcare Diagnostics, Inc.: Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL

Company / brand

Siemens Healthcare Diagnostics, Inc.

Product

Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL

Reason / hazard

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

Status

Ongoing

Distribution / 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 part of USA and the countries of Canada, South Africa, Brazil, Chile, Colombia.

Recall initiated

2026-06-26

Code info

UDI-DI 00842768014321 Lot U2

Product quantity

494 US; 114 OUS

Voluntary mandated

Voluntary: Firm initiated

City

East Walpole

State

MA

Country

United States

Event id

99381

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