Syva Emit Disopyramide calibrator recalled for azide concentration
Lot U1 of the Syva Emit Disopyramide Enzyme Immunoassay calibrator has an out-of-specification sodium azide concentration. The notice says assay results were not affected, and the health risk to lab technicians is low, with the worst outcome being mild skin or eye irritation. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Siemens recalls
What to do
- Set aside Syva Emit Disopyramide Calibrator Lot U1 and don't use it.
- Check for UDI-DI 00842768001406 with Lot U1 on your calibrator kits.
- The notice doesn't say how to get a replacement; contact Siemens Healthcare Diagnostics.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 8 US; 44 OUS
- Illnesses reported
- None reported
- Manufactured in
- 500 Gbc Dr, Newark, DE, United States
- Classification
- Class III
- Recall number
- Z-2880-2026
In the FDA's words
- Description
- Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL 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. UDI-DI 00842768001406 Lot U1 Distribution: Worldwide - US Nationwide distribution in the states of CA and VA. The country of Japan. Affected quantity: 8 US; 44 OUS
- Hazard
- 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.
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