Syva Emit Disopyramide Assay Enzyme Immunoassay recall (Siemens Healthcare Diagnostics, Inc.)

Medical deviceClass IIIOngoing

Summary: Siemens Healthcare Diagnostics, Inc. is recalling 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.

What is being recalled

Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL

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.

How serious is it

Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.

Where it was sold

Worldwide - US Nationwide distribution in the states of CA and VA. The country of Japan. (states named: California, Virginia)

How to tell if yours is affected

UDI-DI 00842768001406 Lot U1

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

More recalls from Siemens Healthcare Diagnostics, Inc. · all medical device recalls · recalls from June 2026

Official FDA record