Syva® Emit® tox™ Tricyclic Antidepressants Calibrator/Controls 10445390Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · Syva® Emit® tox™ Tricyclic Antidepressants Calibrator/Controls, 3 levels · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Jun 26, 2026Class IIIOpen, Classified
out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. 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.
Z-2881-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other RADIOIMMUNOASSAY, TRICYCLIC ANTIDEPRESSANT DRUGS devices
- NA DOA-1127-041-19Alere San Diego, Inc. · Radioimmunoassay, Tricyclic Antidepressant Drugs1 recall1 report
- AlereTM iScreen® IS5MInstant Technologies, Inc. · Radioimmunoassay, Tricyclic Antidepressant Drugs1 recall0 reports
- iCup® I-DUA-157-013Instant Technologies, Inc. · Radioimmunoassay, Tricyclic Antidepressant Drugs1 recall0 reports
- iCup® I-DUA-167-022Instant Technologies, Inc. · Radioimmunoassay, Tricyclic Antidepressant Drugs1 recall0 reports
- reditest® 011020119Redwood Toxicology Laboratory, Inc. · Radioimmunoassay, Tricyclic Antidepressant Drugs3 reports
- AlereTM iScreen® IS9Instant Technologies, Inc. · Radioimmunoassay, Tricyclic Antidepressant Drugs1 report
- iCup® I-DOA-197-251Instant Technologies, Inc. · Radioimmunoassay, Tricyclic Antidepressant Drugs1 report
- iCup® I-DUE-1107-141Instant Technologies, Inc. · Radioimmunoassay, Tricyclic Antidepressant Drugs1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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