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 |
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.
How to identify the recalled item
| Lot / date codes | Lot Number: 2215125/UDI: 00815381020390 |
|---|---|
| Lot / date codes | Lot #s:0883425,0878825/DI: 00815381020192 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
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.