Syva Emit tox Serum Tricyclic Antidepressant… recallZ-2881-2026 · Siemens Healthcare Diagnostics, Inc. · initiated Jun 26, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
On June 26, 2026, the firm began notifying customers via Urgent Medical Device Correction letters. Customers were informed of the issue and provided with revised Safety Data Sheets (SDS) specific to the impacted lots for handling and disposal information.
Recall details
- Recall number
- Z-2881-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 26, 2026
- Posted by the FDA
- Aug 4, 2026
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 494 US; 114 OUS
- Product code
- LFG
- FDA submissions
- K821743
- 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.
Product description
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
Code information (models, lots, serial numbers)
UDI-DI 00842768014321 Lot U2
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Syva® Emit® tox™ Tricyclic Antidepressants Calibrator/Controls 10445390Siemens Healthcare Diagnostics Inc. · RADIOIMMUNOASSAY, TRICYCLIC ANTIDEPRESSANT DRUGS1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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