FDA recall, , Low risk
Syva Emit Disopyramide Assay Enzyme Immunoassay
The Syva Emit Disopyramide Assay has an out-of-specification sodium azide concentration, which can cause mild skin or eye irritation.
Summary by Recall Canary from the FDA notice
What happened
Siemens Healthcare Diagnostics, Inc., of Newark, Delaware, recalled the Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL, because of an out-of-specification sodium azide concentration in the Syva Emit Disopyramide Enzyme Immunoassay Calibrator.
While assay results were not impacted, the overall health risk to lab technicians 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.
The company began the recall on June 26, 2026, and it was added to the FDA's Enforcement Report on August 4, 2026. The product was distributed worldwide, including US Nationwide distribution in the states of CA and VA, and the country of Japan.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
A UDI-DI is the device identifier printed with the barcode on the device label.
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
- UDI-DI
- 00842768001406
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of California and Virginia. The country of Japan.
- Company
- Siemens Healthcare Diagnostics, Inc.Newark, Delaware
- Hazard
- Quality testing problem
- Risk
Low risk
Using it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 99379
- Recall number
- Z-2880-2026
- Quantity recalled
- 8 US; 44 OUS
All recalls from Siemens Healthcare Diagnostics, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
