FDA Medical devices recall ·
Biofire Spotfire Respiratory/Sore Throat Panel recall
- Recall number
- Z-2081-2026
- Date
- (initiated April 1, 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
- 2400 pouches
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Why was it recalled?
Respiratory/sore throat panel test may result in false negative results and control failures.
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
Lot Number: 2215125/UDI: 00815381020390
Distribution
US Nationwide distribution in the states of MS, TX MN, VA.
States: Minnesota Mississippi Texas Virginia
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-2081-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.