BIOFIRE Respiratory Panel 2.1 (RP2.1)
Reason given by FDA: Due to increase in false negative results.
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 a recall of its BioFire Respiratory Panel 2.1 (RP2.1) REF 423742, a PCR-based multiplexed nucleic acid test, on June 24, 2026, due to an increase in false negative results. The recall involves 2,370 pouches (79 kits) and was added to the FDA's Enforcement Report on August 12, 2026. The product was distributed nationwide in the states of Alabama, Arkansas, Iowa, Illinois, Kansas, Louisiana, Minnesota, Missouri, Texas, and Wisconsin.
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 Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
- UDI-DI
- 00815381020529
- Lot
- 3VLB25
- 1872125
Details
- Company began the recall
- Sold in
U.S. Nationwide distribution in the states of Alabama, Arkansas, Iowa, Illinois, Kansas, Louisiana, Minnesota, Missouri, Texas, and Wisconsin.
- Event ID
- 99261
- Recall No.
- Z-2936-2026
- Company
- BioFire Diagnostics, LLCSalt Lake City, Utah
- Hazard
- Device defect
- Quantity recalled
- 2,370 pouches (79 kits)
- Recall type
- Voluntary: Firm initiated
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
