- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- 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.
- Affected products (lot / model / serial)
- UDI-DI 00842768001406 Lot U1
- Units affected
- 8 US; 44 OUS
- Distribution pattern
- Worldwide - US Nationwide distribution in the states of CA and VA. The country of Japan.
- Firm location
- Newark, DE, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2880-2026
- Recall initiated
- June 26, 2026
- FDA classification date
- August 4, 2026
- FDA report date
- August 12, 2026
- FDA event ID
- 99379
- Last updated on HTM Vibe
- August 18, 2026