Syva Emit Disopyramide Assay Enzyme Immunoassay recall
Siemens Healthcare Diagnostics, Inc. recalled Syva Emit Disopyramide Assay Enzyme Immunoassay on August 12, 2026 because of out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. It was sold nationwide.
Why it was recalled
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.
What's recalled
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Quantity: 8 US; 44 OUS
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Siemens Healthcare Diagnostics, Inc., Newark, DE
- Date
- Severity
- Class III
the product is unlikely to cause health problems but breaks a rule. - Where sold
- Nationwide
Worldwide - US Nationwide distribution in the states of CA and VA. The country of Japan. - Status
- Ongoing
- Recall number
- Z-2880-2026
- Source
- U.S. Food and Drug Administration
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