Siemens Tricyclic Antidepressant Calibrator/Controls Recall Lot U2
Siemens Healthcare Diagnostics is recalling Lot U2 of its Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls due to an out-of-specification sodium azide concentration. The recall affects 494 units in the US and 114 units overseas, distributed nationwide and internationally.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall, which by definition is not likely to cause adverse health consequences. The source text states the health risk is low, exposure is limited, and no serious harm is anticipated, with only mild skin or eye irritation as the worst outcome.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Lot U2 of the Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls (Catalog No. 7C219UL) due to an out-of-specification sodium azide concentration. The product is used as a calibrator/control in laboratory assays for detecting tricyclic antidepressants in serum samples.
The recall was initiated because the sodium azide concentration in the lot did not meet specified standards. Sodium azide is a preservative commonly used in laboratory reagents, but at elevated concentrations it can pose health risks. According to the manufacturer, while the assay results were not impacted, the overall health risk to lab technicians is low due to limited exposure from small volumes and a 0.2% post-reconstitution sodium azide concentration.
The affected products were distributed worldwide, including US nationwide distribution in states such as California, Illinois, New York, and others, as well as in Canada, South Africa, Brazil, Chile, and Colombia. A total of 494 units were distributed in the US and 114 units overseas.
Laboratories and healthcare facilities that received the affected lot should discontinue use and contact Siemens Healthcare Diagnostics for replacement or credit. No serious health effects have been reported in connection with this recall, and the worst anticipated outcome is mild skin or eye irritation.
The recalled product
- Product
- Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI 00842768014321 Lot U2
Distribution
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