FDA Medical devices recall ·
BioFire Respiratory Panel 2.1, IVD recall
- Recall number
- Z-0602-2026
- Date
- (initiated October 22, 2025)
- 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
- 97 Kits (2,910 pouches)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Why was it recalled?
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of 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
UDI: 00815381020529 /Lot # 2649724 Expanded Lot#: 1471725
Distribution
US:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC OUS: None
States: Arizona Florida Georgia Idaho North Carolina New Hampshire New Jersey New York Oregon Pennsylvania South Carolina
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-0602-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.