LowFDAOngoing
Unlikely to make you ill, but it breaks the rules.
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Check your package for
UDI-DI 00842768001406 Lot U1
- Why
- 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.
- Distributed
- Worldwide - US Nationwide distribution in the states of CA and VA. The country of Japan.
- Company
- Siemens Healthcare Diagnostics, Inc.
- Announced
- Recall began