FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
- Recall number
- Z-2880-2026
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
- Status
- Open, Classified
- Initiated
- 2026-06-26
- Posted
- 2026-08-04
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- UDI-DI 00842768001406 Lot U1
- 510(k) numbers
- ["K801204"]
- PMA numbers
- not on file
- Product code
- KLR
- Firm FEI
- 2517506
- Firm city
- Newark
- Firm state
- DE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28