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Syva Emit Tox Tricyclic Antidepressant Calibrator/Controls
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MEDICAL DEVICE RECALLLOW

Syva Emit Tox Tricyclic Antidepressant Calibrator/Controls

Siemens recalls Syva Emit Tox Tricyclic Antidepressant Calibrator/Controls due to out-of-specification sodium azide concentration.

What to do

Stop using the recalled calibrator/controls immediately. Contact Siemens Healthcare Diagnostics for instructions on returning the affected product and obtaining a replacement.

Recalled
Listed
Updated
Recall No.
Z-2881-2026
Agency
FDA
Firm
Siemens Healthcare Diagnostics, Inc.
Recall ID
99381
Status
ONGOING

Recall at a glance

Quantity recalled
494 US; 114 OUS

Why it was recalled

Siemens Healthcare Diagnostics is recalling Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls due to out-of-specification sodium azide concentration in Lot U2. The assay results were not impacted, but the elevated sodium azide level may cause mild skin or eye irritation to lab technicians upon exposure.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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

UDI-DI
00842768014321

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Failed Specifications recalls

Other recent recalls from Siemens Healthcare Diagnostics, Inc.

All recalls from Siemens Healthcare Diagnostics, Inc.

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Editorial summary by Recall Canary · summary updated 2026-08-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification