FilmArra Pneumonia Panel plus — Class II medical device recall Z-1518-2025
Ongoing recall by BioFire Diagnostics, LLC, reported 2025-04-16. Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
| Recall number | Z-1518-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioFire Diagnostics, LLC, Salt Lake City, UT, United States |
| Recall initiated | 2025-02-27 |
| Classified | 2025-04-04 |
| Reported by FDA | 2025-04-16 |
| Countries outside the US | CH, ES, FR, IL |
| Quantity | 29 kits |
| UPC / GTIN / UDI-DI | 00815381020314 |
| Lot numbers | 0979424 |
| Model numbers | RFIT-LBL-0374 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1518-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.