FDA Device recall Z-0993-2024
FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)
- FDA Device
- Class II
- ongoing
- Published 2024-02-14
On 2024-02-14 the FDA classified a Class II recall of FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit) by Biofire Diagnostics, citing their is a potential for false positive results when using Pneumonia panel.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0993-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-14 |
| Published | 2024-02-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Biofire Diagnostics |
| Distribution | US |
Product
FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)
Reason
Their is a potential for false positive results when using Pneumonia panel.
Identifiers
| code_info | UDI: 00815381020314/ All unexpired lots |
|---|
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-0993-2024%22
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