Benzodiazepine Intercept 5 Plate Kit 1110IBRecalls & reported problems
Orasure Technologies, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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.
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
- Jul 13, 2020Class IIITerminated
Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
Z-2876-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other Enzyme Immunoassay, Benzodiazepine devices
- ONLINE DAT Benzodiazepines Plus 08056919190Roche Diagnostics GmbH · Enzyme immunoassay, benzodiazepine5 reports
- Benzodiazepines Plus 4490789190Roche Diagnostics GmbH · Enzyme immunoassay, benzodiazepine5 reports
- ONLINE DAT Benzodiazepines II 04939417190Roche Diagnostics GmbH · Enzyme immunoassay, benzodiazepine3 reports
- VITROS 6801989Ortho-Clinical Diagnostics, Inc. · Enzyme immunoassay, benzodiazepine3 reports
- ONLINE DAT Benzodiazepines II 08056927190Roche Diagnostics GmbH · Enzyme immunoassay, benzodiazepine2 reports
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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