FDA Devices recall · Reported August 12, 2026
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
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 …
Siemens Healthcare Diagnostics, Inc. recalled Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N3… - a low-severity action.
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N3… was recalled by Siemens Healthcare Diagnostics, Inc. in August 12, 2026. Reason: Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U…. Check the official notice for the remedy. Verify recall #Z-2880-2026 with the FDA Devices before acting.
The recall
Siemens Healthcare Diagnostics, Inc. issued this low-severity FDA Devices recall-Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U….
- Low
- severity level
- Class III
- classification
- August 12, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2880-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2880-2026) was formally reported on August 12, 2026, with the manufacturer initiating the action on June 26, 2026. It is classified under Low severity (Class III), with a current status of Ongoing. Siemens Healthcare Diagnostics, Inc. is listed as the recalling firm, operating out of Newark, DE. Federal records list the affected scope as 8 US; 44 OUS.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: Worldwide - US Nationwide distribution in the states of CA and VA. The country of Japan.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Ongoing |
| Recall number | Z-2880-2026 |
| Date reported | August 12, 2026 |
| Date initiated | June 26, 2026 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Firm location | Newark, DE |
| Affected scope | 8 US; 44 OUS |
| Distribution | Worldwide - US Nationwide distribution in the states of CA and VA. The country of Japan. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2880-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Similar severity · nearest report date
Same archive severity grade (Low), closest by report date among other firms and states.
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Methodology · Corrections · Archive as of August 2026