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Siemens Healthcare Diagnostics, Inc.: Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL

Medical DevicesSource: FDA (device) · Date: 2026-08-12

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Siemens Healthcare Diagnostics, Inc.
Product
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Reason / 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.
Classification
Class III
Status
Ongoing
Distribution / sold at
Worldwide - US Nationwide distribution in the states of CA and VA. The country of Japan.
Recall initiated
2026-06-26
Code info
UDI-DI 00842768001406 Lot U1
Product quantity
8 US; 44 OUS
Voluntary mandated
Voluntary: Firm initiated
City
Newark
State
DE
Country
United States
Event id
99379
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