FDAFDA recall Z-2936-2026 · Aug 19, 2026
BioFire Diagnostics, LLC: BIOFIRE Respiratory Panel 2 recall
Recall found
Product
BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
Reason for recall
Due to increase in false negative results
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Part Number: 423742 UDI-DI code: 00815381020529 Pouch Lot: 3VLB25 Kit Lot: 1872125
- Quantity
- 2,370 pouches (79 kits)
- Distribution
- U.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO, TX, and WI.
- Recalling firm
- BioFire Diagnostics, LLC, Salt Lake City, UT
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-24
Source: openFDA enforcement record Z-2936-2026 · search recall number Z-2936-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.