Z-2880-2026 Class III Ongoing
FDA device recall Z-2880-2026 was initiated by Siemens Healthcare Diagnostics, Inc. on June 26, 2026 and is designated Class III. 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 du… The recall status is ongoing. Affected quantity: 8 US; 44 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- August 12, 2026
- Initiation Date
- June 26, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 US; 44 OUS
Product Description
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
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.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of CA and VA. The country of Japan.
Code Information
UDI-DI 00842768001406 Lot U1