BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel 423485Recalls & reported problems
Biofire Diagnostics, LLC · IVD reagent kit containing 30 tests. · 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
- Apr 1, 2026Class IIOpen, Classified
Respiratory/sore throat panel test may result in false negative results and control failures.
Z-2081-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other Bordetella Pertussis Dna Assay System devices
- Solana M308Diagnostic Hybrids, Inc. · Bordetella pertussis dna assay system1 recall0 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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