Siemens Healthcare Diagnostics, Inc. recalls Syva Emit Disopyramide Assay Enzyme Immunoassay
- Recalling company
- Siemens Healthcare Diagnostics, Inc.
- Product
- Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
- Reason
- 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.
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- Jun 26, 2026
- Reported
- Aug 12, 2026
- Distribution
- Worldwide - US Nationwide distribution in the states of CA and VA. The country of Japan.
- Status
- Ongoing
- Quantity
- 8 US; 44 OUS
- Lot / codes
- UDI-DI 00842768001406 Lot U1
- Company location
- Newark, DE
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2880-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2880-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.