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Z-2881-2026Class III

Siemens Healthcare Diagnostics, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Siemens Healthcare Diagnostics, Inc.
Product type
Device
Status
Ongoing
Report date
2026-08-12
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.
Firm state
MA
Product quantity
494 US; 114 OUS
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
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.

Product description

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

Code / lot info

UDI-DI 00842768014321 Lot U2

Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →