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Class IIIOngoing

Siemens Healthcare Diagnostics, Inc. recalls Syva Emit Disopyramide Assay Enzyme Immunoassay

Recall date · record updated Aug 12, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Siemens Healthcare Diagnostics, Inc.
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.
Hazard
FDA Class III: not likely to cause adverse health consequences (FDA definition).
Who’s affected
Worldwide - US Nationwide distribution in the states of CA and VA. The country of Japan.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99379…

Products

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

    Codes/lots: UDI-DI 00842768001406 Lot U1Quantity: 8 US; 44 OUSRecall no. Z-2880-2026Class III

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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