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.
“Siemens Healthcare Syva Emit Tox Serum Calibrators Recall: Low Sodium Azide Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/314302-siemens-healthcare-syva-emit-tox-serum-calibrators-recall-low-sodium. Based on FDA recall #Z-2881-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2881-2026%22&limit=1).
The FDA announced on June 26, 2026, that Siemens Healthcare Diagnostics, Inc. is recalling Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls due to out-of-specification sodium azide concentration. The agency classified the recall as Class III and ongoing.
The recall addresses an out-of-specification sodium azide concentration in the product. While assay results were not impacted, exposure could cause mild skin or eye irritation for lab technicians, though no serious harm is anticipated.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has had 150 other recalls since June 7, 2017. Recent similar recalls include the Atellica CH Revised C-Reactive Protein recall on Aug. 17, 2026, and the Syva EMIT 2000 Quinidine Assay recall on July 13, 2026. Other recent recalls of similar products include the Spectra Medical Devices Sodium Chloride Injection Recall (July 6, 2026) and the Medline Perfusion Syringe Recall (Oct. 27, 2025).
How to tell if you have this one
Check for the product name 'Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls', catalog number 7C219UL, and lot number U2. The product was sold with UDI-DI 00842768014321.
Brand
Siemens Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the product by catalog number 7C219UL and lot number U2.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 14 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Idaho, Illinois, Indiana, Massachusetts, Mississippi, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Washington.
Recall timeline
FDA published this recall 47 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2881-2026 (June 26, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2881-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.