Quick Facts at a Glance
- Recall Date
- April 1, 2026
- Hazard Level
- HIGH
- Brand
- BioFire Diagnostics
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- BioFire Diagnostics
- Model numbers
- Lot Number: 2215125/UDI: 00815381020390
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
April 1, 2026
Reported by FDA DEVICE
May 13, 2026
RecallRadar source check
May 20, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Respiratory/sore throat panel test may result in false negative results and control failures.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact BioFire Diagnostics, LLC or your healthcare provider for instructions. Notification method: E-Mail
Get instant alerts for BioFire Diagnostics recalls
Be the first to know. Free instant alerts to your inbox.
Full Description
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485. Reason: Respiratory/sore throat panel test may result in false negative results and control failures.. Classification: Class II. Quantity: 2400 pouches. Distribution: US Nationwide distribution in the states of MS, TX MN, VA.
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
Get instant alerts for recalls that affect you. Free forever.