Z-1518-2025 Class II Ongoing
FDA device recall Z-1518-2025 was initiated by BioFire Diagnostics, LLC on February 27, 2025 and is designated Class II. Reason for recall: Increased risk of control failures and false negative test results with multiplexed nucleic acid test. The recall status is ongoing. Affected quantity: 29 kits.
Recall Details
- Product Type
- Devices
- Report Date
- April 16, 2025
- Initiation Date
- February 27, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29 kits
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.
Distribution Pattern
OUS International Distribution to countries of: France, Italia, Spain, Switzerland, Israel
Code Information
UDI: 00815381020314/Lot# 0979424