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Syva Emit Disopyramide Assay
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MEDICAL DEVICE RECALLLOW

Syva Emit Disopyramide Assay

Siemens recalls Syva Emit Disopyramide Assay due to out-of-spec sodium azide concentration; risk of mild irritation.

What to do

Locate any Syva Emit Disopyramide Assay kits with Lot U1 and discontinue use. Contact Siemens Healthcare Diagnostics for instructions on returning the affected product.

Recalled
Listed
Updated
Recall No.
Z-2880-2026
Agency
FDA
Firm
Siemens Healthcare Diagnostics, Inc.
Recall ID
99379
Status
ONGOING

Recall at a glance

Quantity recalled
8 US; 44 OUS

Why it was recalled

Siemens Healthcare Diagnostics is recalling the Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370, Catalog No 6N319UL, due to an out-of-specification sodium azide concentration in the calibrator lot. Although assay results are not affected, exposure to the affected calibrator may cause mild skin or eye irritation.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL

UDI-DI
00842768001406

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-08-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification