DeviceSignal · Recall classified
Siemens Healthcare Diagnostics, Inc.
FDA classified a device recall on 2026-08-04 · Class III · Z-2880-2026
EventRecall classified
Effective2026-08-04
ClassificationClass III
On 2026-08-04 the FDA classified a device recall from Siemens Healthcare Diagnostics, Inc. as Class III. Product: Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No…. Recall Z-2880-2026. The firm initiated it on 2026-06-26. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2880-2026
- Classification
- Class III
- Classified on
- 2026-08-04
- Initiated on
- 2026-06-26
- Firm
- 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.
- Product
- Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2880-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
c8987052cc937be5c55d22a9e8c496be3b4773766835bef76351b27533ab447b- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)