FDA Device recall Z-1518-2025
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
- FDA Device
- Class II
- ongoing
- Published 2025-04-16
On 2025-04-16 the FDA classified a Class II recall of FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374 by Biofire Diagnostics, citing increased risk of control failures and false negative test results with multiplexed nucleic acid test.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1518-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-27 |
| Published | 2025-04-16 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Biofire Diagnostics |
| Distribution | n/a |
Product
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Reason
Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
Identifiers
| code_info | UDI: 00815381020314/Lot# 0979424 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1518-2025%22
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