BIOFIRE Respiratory Panel 2.1 recall (BioFire Diagnostics, LLC)
Medical deviceClass IIOngoing
Summary: BioFire Diagnostics, LLC is recalling BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic. Reason: Due to increase in false negative results.
What is being recalled
BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
Why
Due to increase in false negative results
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
U.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO, TX, and WI. (states named: Alabama, Arkansas, Iowa, Illinois, Kansas, Louisiana, Minnesota, Missouri, Texas, Wisconsin)
How to tell if yours is affected
Part Number: 423742 UDI-DI code: 00815381020529 Pouch Lot: 3VLB25 Kit Lot: 1872125
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2936-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 24, 2026 |
| Reported | August 19, 2026 |
| Company | BioFire Diagnostics, LLC |
| Company location | Salt Lake City, UT, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 2,370 pouches (79 kits) |
More recalls from BioFire Diagnostics, LLC · all medical device recalls · recalls from June 2026