Biofire Spotfire Respiratory/Sore Throat Panel
The respiratory/sore throat panel test may result in false negative results and control failures.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
BioFire Diagnostics, LLC of Salt Lake City, Utah, began the recall on April 1, 2026, of the BioFire Spotfire Respiratory/Sore Throat Panel REF: 423485, 2400 pouches. The respiratory/sore throat panel test may result in false negative results and control failures. The recall was added to the FDA's Enforcement Report and classified by the FDA on May 6, 2026, and in the FDA's weekly enforcement report on May 13, 2026. The distribution was US Nationwide distribution in the states of MS, TX MN, VA.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
- UDI-DI
- 00815381020390
- Lot
- 2215125
Details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Mississippi, Texas Minnesota, Virginia.
- Event ID
- 98719
- Recall No.
- Z-2081-2026
- Company
- BioFire Diagnostics, LLCSalt Lake City, Utah
- Hazard
- Device defect
- Quantity recalled
- 2400 pouches
- Recall type
- Voluntary: Firm initiated
- Customers told by
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
