FilmArray Pneumonia Panel — Class II medical device recall Z-0994-2024
Ongoing recall by BioFire Diagnostics, LLC, reported 2024-02-14, distributed nationwide. Their is a potential for false positive results when using Pneumonia panel.
| Recall number | Z-0994-2024 |
|---|---|
| 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 | 2023-12-14 |
| Classified | 2024-02-06 |
| Reported by FDA | 2024-02-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BO, BR, CN, CO, CR, DO, EC, GT, HK, HN, JP, KR, MX, NI, PA, PE, PH, PY, SG, SV, TH, TW, UY, VE |
| Quantity | 274,290 units |
| UPC / GTIN / UDI-DI | 00815381020178 |
| Model numbers | 2797, FIT-ASY-0144 |
Product
FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)
Reason for recall
Their is a potential for false positive results when using Pneumonia panel.
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-0994-2024. 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.