FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Reported: April 16, 2025 Initiated: February 27, 2025 #Z-1518-2025
Product Description
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Reason for Recall
Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
Details
- Recalling Firm
- BioFire Diagnostics, LLC
- Units Affected
- 29 kits
- Distribution
- OUS International Distribution to countries of: France, Italia, Spain, Switzerland, Israel
- Location
- Salt Lake City, UT
Frequently Asked Questions
What product was recalled? ▼
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374. Recalled by BioFire Diagnostics, LLC. Units affected: 29 kits.
Why was this product recalled? ▼
Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 16, 2025. Severity: Moderate. Recall number: Z-1518-2025.
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