Test Kit Recall: BioFire Spotfire Panel
Announced 2026-05-13 · FDA
BioFire Spotfire Respiratory/Sore Throat Panel REF: 423485 is recalled. About 2,400 pouches distributed nationwide to Mississippi, Texas, Minnesota, and Virginia are affected. The issue is potential false negative results and control failures; lot number 2215125 and UDI 00815381020390 are involved.
| Brand | BioFire Diagnostics, LLC |
|---|---|
| Product | Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485 |
| Reason | Respiratory/sore throat panel test may result in false negative results and control failures. |
| Severity | moderate |
| Units affected | 106 |
| Distribution | US Nationwide distribution in the states of MS, TX MN, VA. |
| Agency | FDA |
| Recall / campaign no. | Lot Number: 2215125/UDI: 00815381020390 |
WHAT YOU SHOULD DO
- Stop using the recalled pouches immediately and set them aside.
- Contact BioFire Diagnostics to arrange return, replacement, or remedy; provide lot number 2215125 and UDI 00815381020390.
- If testing has already been performed, consult the facility or your healthcare provider about potential impact.
- Monitor for updates from FDA and BioFire Diagnostics and follow their instructions.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.