Siemens Healthcare recalls Syva Emit Disopyramide Assay kits with potential low sodium azide risk. Lab technicians may experience mild skin or eye irritation but serious injury is unlikely.
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 is recalling Syva Emit Disopyramide Assay kits due to a small risk of mild skin or eye irritation for lab technicians handling the product. The hazard is low because exposure is limited to small volumes and the sodium azide concentration is low.
The assay kits contain a small amount of sodium azide that could cause mild skin or eye irritation if exposed. However, the risk is low because lab technicians handle small volumes and the sodium azide concentration is very low (0.2%).
Lab technicians who handle the Syva Emit Disopyramide Assay kits are most at risk. The recall affects specific lots of the assay kits used in medical testing.
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.
Look for the lot number U1 on the Syva Emit Disopyramide Assay kit.
No, the recall is for low risk. Lab technicians may experience mild skin or eye irritation but serious injury is unlikely.
The recall does not require immediate action. Check the lot number to see if your kit is affected.
Your kit is recalled if it has lot number U1 and catalog number 6N319UL.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2880-2026 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2880-2026 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
