FDA Reports Class III Recall for Siemens Antidepressant Calibrator Solutions

An ongoing Class III recall addresses out-of-specification sodium azide levels in specific laboratory diagnostic calibrator lots.

By AI ReporterWritten Aug 18, 2026, 1:24 a.m. ET

Developing · not yet checked for updates

This recall is open. The agency updates its record as an action is expanded, reclassified or terminated, and this page is rewritten when it does.

We have not yet searched for new coverage of this beyond the reports listed below.

FDA enforcement reports show an recall initiated on June 26, 2026, and posted on August 12, 2026, for Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls manufactured by The action is open and developing under recall number . The FDA defines as its least serious recall category, applied when product use is not likely to cause harm. According to diagnostic background publications, the product is an in vitro diagnostic laboratory reagent used by clinical chemistry and toxicology laboratories to calibrate and verify automated chemistry analysers testing human serum or plasma samples. It is not a consumer good or food item. The recall affects 494 units in the U.S. and 114 units outside the U.S., covering UDI-DI 00842768014321 Lot U2, with product description SMN 10445390 and Catalog No. 7C219UL. Distribution includes U.S. nationwide locations across CA, ID, IL, IN, MA, MS, NC, NM, NY, OH, OK, OR, PA, WA, and the Northern Mariana Islands, alongside Canada, South Africa, Brazil, Chile, and Colombia. An official FDA enforcement report indicates the recall was prompted by an out-of-specification sodium azide concentration in Lot U2. Assay results were not impacted, and the overall health risk to laboratory technicians is low because exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst potential outcome being mild skin or eye irritation and no serious harm anticipated. The agency's enforcement database lists no other recall actions for

Was this report accurate and useful?

Sources

Revision history

Version 118 Aug 2026, 05:24current
First published.

How we work

This site models an investigative reporter rather than a wire desk. The aim is the most complete, accurate and timely account we can assemble — all three, not a trade between them. Reports go out within minutes of the coverage they are built from, carrying context a newsroom would otherwise need a day and a records request to gather: what has happened at this place before, what the operator’s record is, which aircraft it actually was.

Reports are built from primary sources — accident and court records, official registries, weather observations, agency statements — and from reputable news organisations, each named where their reporting is used. Facts are extracted before anything is written, and every one must be supported by a quotation found in the source itself; the model that writes the report is given only those verified facts and never sees the article, so it cannot introduce a detail no source stated.

Where sources disagree we publish the disagreement, attributed, rather than picking a figure. Where a fact comes from a record rather than a reporter, we say so, and the language matches: an instrument reading is never described as something anyone confirmed. Some things are deliberately withheld — a suspect is not named until an agency names them on the record, victims until families or officials release them — and corrections appear as visible revisions, never as silent edits.

None of that makes a report true. A quotation check proves a source said something, not that it was right, and an automated system can be confidently wrong in ways the checks do not catch. If something here is wrong, the feedback above is how it gets found. The full methodology, including what we refuse to publish.