FDA Medical devices recall ·
BIOFIRE Respiratory Panel 2.1 (RP2.1) recall
- Recall number
- Z-2936-2026
- Date
- (initiated June 24, 2026)
- Company / brand
- BioFire Diagnostics, LLC
515 S Colorow Dr, Salt Lake City, UT, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2,370 pouches (79 kits)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
Why was it recalled?
Due to increase in false negative results
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Part Number: 423742 UDI-DI code: 00815381020529 Pouch Lot: 3VLB25 Kit Lot: 1872125
Distribution
U.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO, TX, and WI.
States: Alabama Arkansas Iowa Illinois Kansas Louisiana Minnesota Missouri Texas Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2936-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.