Siemens Syva Emit Disopyramide Assay Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Siemens Healthcare Diagnostics, Inc. is recalling Syva Emit Disopyramide Assay due to out-of-specification sodium azide concentration in the calibrator.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 19, 2026 and geographically references United States. Its severity classification of "low" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, devices.
What Happened
Siemens Healthcare Diagnostics, Inc. initiated a voluntary recall of the Syva Emit Disopyramide Assay because of an out-of-specification sodium azide concentration in the calibrator lot. The assay results were not impacted, and the health risk to lab technicians is low.
Which Products Are Affected
The affected product is Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine, SMN 10445370, Catalog No 6N319UL, Lot U1 (UDI-DI 00842768001406). A total of 8 units were distributed in the US and 44 units outside the US. Distribution included the states of CA and VA, as well as Japan.
What You Should Do
Consumers should follow the instructions provided in the firm's notification letter for handling the recalled product.
Why This Matters
The issue poses a low health risk, with potential mild skin or eye irritation as the worst outcome and no serious harm anticipated.
Source
FDA recall number Z-2880-2026 (https://www.fda.gov)
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (967 characters here).
Similar severity timing
Same severity (low) notices issued closest in time to August 19, 2026.
Frequently Asked Questions
Common questions about this FDA recall.