FDA Medical devices recall ·
FilmArra Pneumonia Panel plus (Pneumoplus) recall
- Recall number
- Z-1518-2025
- Date
- (initiated February 27, 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
- 29 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Why was it recalled?
Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
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: 00815381020314/Lot# 0979424
Distribution
OUS International Distribution to countries of: France, Italia, Spain, Switzerland, Israel
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-1518-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.