Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. 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 Disopyramide Assay Recall: Low Sodium Azide Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/314305-siemens-healthcare-syva-emit-disopyramide-assay-recall-low-sodium-azide. Based on FDA recall #Z-2880-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2880-2026%22&limit=1).
The FDA announced on June 26, 2026, that Siemens Healthcare Diagnostics is recalling the Syva Emit Disopyramide Assay due to out-of-specification sodium azide concentration. The agency stated the health risk to lab technicians is low with no serious harm anticipated.
The recall addresses an out-of-specification sodium azide concentration in the Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. The FDA said 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.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics has 150 other recalls on record since June 7, 2017. Other recent recalls of similar products include Atellica CH Revised C-Reactive Protein (RCRP) (Aug. 17, 2026), Syva EMIT 2000 Quinidine Assay (July 13, 2026), and Atellica CH Urine Albumin (July 6, 2026). Other recent recalls of similar products include Medline Blood Culture Kit (Dec. 24, 2025), Medline Perfusion Syringe (Oct. 27, 2025), and Siemens Healthineers Immulite 2000 Syphilis Screen (July 13, 2026).
How to tell if you have this one
Check for the lot number U1 on the Syva Emit Disopyramide Assay kit. The product has catalog number 6N319UL and was sold with UDI-DI 00842768001406.
Brand
Siemens Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Number
Look for the lot number U1 on the Syva Emit Disopyramide Assay kit.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of CA and VA. The country of Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Virginia.
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-2880-2026 (June 26, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2880-2026 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.