FDA Device recall Z-2880-2026
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
- FDA Device
- Class III
- ongoing
- Published 2026-08-12
On 2026-08-12 the FDA classified a Class III recall of Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL by Siemens Healthcare Diagnostics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2880-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-06-26 |
| Published | 2026-08-12 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
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.
Identifiers
| code_info | UDI-DI 00842768001406 Lot U1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2880-2026%22
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