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Syva Emit Tox Serum Tricyclic Recall

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

Updated June 26, 2026

Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2 contains an out-of-specification concentration of sodium azide. Lab technicians may experience mild skin or eye irritation from exposure, though the overall health risk is low due to the small volumes used.

Is the Siemens Healthcare Diagnostics, Inc. recalled? Yes. This product was recalled by FDA on June 26, 2026. Details below.

What is recalled

Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls, SMN 10445390, Catalog No. 7C219UL, Lot U2, manufactured by Siemens Healthcare Diagnostics, Inc.

Am I affected

You are affected if your laboratory uses Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls with Lot number U2.

What to do right now

Stop using Lot U2 of this product. Contact Siemens Healthcare Diagnostics, Inc. for instructions on how to dispose of or replace the affected controls.

The 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.

Brands affected

Siemens Healthcare Diagnostics, Inc.
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-2881-2026
Classification
Class III
Recalled
June 26, 2026
Read the official notice

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