Siemens Healthcare Diagnostics, Inc.: Enzyme Immunoassay, Lidocaine
Siemens Healthcare Diagnostics is recalling Syva Emit Disopyramide Assay Calibrator Lot U1 because it contains an incorrect concentration of sodium azide, a preservative used in the product. The assay results themselves were not affected, but lab technicians who handle the product could potentially experience mild skin or eye irritation from exposure to the chemical. The recall affects laboratories nationwide in the US, as well as facilities in California, Virginia, and Japan.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-26
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution in the states of CA and VA. The country of Japan.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/4873f41d-2344-4b11-99ab-2810c84f6e1c