FDA Medical devices recall ·
BioFire Respiratory Panel 2.1 plus Kit recall
- Recall number
- Z-1877-2025
- Date
- (initiated April 30, 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
- 30 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
Why was it recalled?
Due to manufacturing error, respiratory panel may result in elevated control failures and/or 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
Lot# 1475424/ UDI: None
Distribution
International distribution in the country of Singapore.
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-1877-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.