Syva Emit Disopyramide Assay Enzyme Immunoassay recall
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Why was Syva Emit Disopyramide Assay Enzyme Immunoassay 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI 00842768001406 Lot U1
- Product
- Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 8 US; 44 OUS
- Distribution
- Worldwide - US Nationwide distribution in the states of CA and VA. The country of Japan.
- Recall date
- August 12, 2026
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)