FDA Medical devices recall ·
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 recall
- Recall number
- Z-2880-2026
- Date
- (initiated June 26, 2026)
- Company / brand
- Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr, Newark, DE, United States - Category
- Medical devices › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 8 US; 44 OUS
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Why was it 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 you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI 00842768001406 Lot U1
Distribution
Worldwide - US Nationwide distribution in the states of CA and VA. The country of Japan.
States: California Virginia
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (medical devices), recall Z-2880-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.