Recall Z-2880-2026 ยท KLR Enzyme Immunoassay, Lidocaine
Siemens Healthcare Diagnostics, Inc.
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
| Date | Aug 4, 2026 (initiated Jun 26, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 8 US; 44 OUS |
| Distribution | Worldwide - US Nationwide distribution in the states of CA and VA. The country of Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K801204 | EMIT DISOPYRAMIDE ASSAY Syva Co., Jun 9, 1980 |