FDA Device recall Z-2440-2023
FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
- FDA Device
- Class II
- ongoing
- Published 2023-08-30
On 2023-08-30 the FDA classified a Class II recall of FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only by Biofire Diagnostics, citing due to manufacturing issue, panels may result in false negative results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2440-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-08 |
| Published | 2023-08-30 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biofire Diagnostics |
| Distribution | CA, CO, CT, FL, GA, IA, IL, IN, LA, MA, MI, MO, MT, NC, NE, NJ, NM, NY, OH, OK, PA, TN, UT, WV |
Product
FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
Reason
Due to manufacturing issue, panels may result in false negative results.
Identifiers
| code_info | Pouch Lot # 2NBT22 /Kit # 2187822 ;UDI-DI: UDI: 00815381020482 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2440-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.