Siemens Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Siemens Healthcare Diagnostics, Inc. is recalling Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls due to out-of-specification sodium azide concentration.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 18, 2026 and geographically references United States. Its severity classification of "low" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Siemens Healthcare Diagnostics, Inc. initiated a voluntary recall of Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls after identifying an out-of-specification sodium azide concentration in Lot U2. While assay results were not impacted, the firm noted a low overall health risk to lab technicians.
Which Products Are Affected
The recall affects Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390, Catalog No. 7C219UL, UDI-DI 00842768014321, Lot U2. A total of 494 units were distributed in the US and 114 units outside the US. Distribution includes the states CA, ID, IL, IN, MA, MS, NC, NM, NY, OH, OK, OR, PA, WA, and Northern Mariana Islands, as well as Canada, South Africa, Brazil, Chile, and Colombia. The recall number is Z-2881-2026.
What You Should Do
Lab technicians and facilities should follow guidance from Siemens Healthcare Diagnostics, Inc. regarding the recalled calibrator/controls.
Why This Matters
The issue involves a low health risk limited to potential mild skin or eye irritation from small volumes of 0.2% post-reconstitution sodium azide concentration, with no serious harm anticipated.
Source
FDA recall Z-2881-2026
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,218 characters here).
Similar severity timing
Same severity (low) notices issued closest in time to August 18, 2026.
Frequently Asked Questions
Common questions about this FDA recall.