Syva Emit Disopyramide Assay recallZ-2880-2026 · Siemens Healthcare Diagnostics, Inc. · initiated Jun 26, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
On 6/26/2026, Siemens issued Urgent Medical Device Correction letters to all affected customers informing them of the issue and providing instructions. Customers are instructed to refer to the SDS which were created and provided with the Urgent Medical Device Corrections and the Urgent Field Safety Notices specifically for Syva Emit Disopyramide Assay Lot U1 for information regarding handling and disposal.
Recall details
- Recall number
- Z-2880-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 26, 2026
- Posted by the FDA
- Aug 4, 2026
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 8 US; 44 OUS
- Product code
- KLR
- FDA submissions
- K801204
- Distribution
- Worldwide - US Nationwide distribution in the states of CA and VA. The country of Japan.
Product description
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Code information (models, lots, serial numbers)
UDI-DI 00842768001406 Lot U1
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Syva® Emit® Disopyramide Assay 10445370Siemens Healthcare Diagnostics Inc. · ENZYME IMMUNOASSAY, LIDOCAINE1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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