FDA Device recall Z-2683-2024
BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
- FDA Device
- Class II
- ongoing
- Published 2024-08-28
On 2024-08-28 the FDA classified a Class II recall of BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143 by Biofire Diagnostics, citing pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2683-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-10 |
| Published | 2024-08-28 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Biofire Diagnostics |
| Distribution | US |
Product
BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
Reason
Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.
Identifiers
| code_info | UDI-DI: 00815381020314. Lot/Expiration: 2147723/27-Aug-2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Biofire Diagnostics
- Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel plus Model/Catalog Number: RFIT-ASY-0143 (30 Kit), R…
FDA Device · Class II · 2026-10-21 · Biofire Diagnostics - Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0…
FDA Device · Class II · 2026-10-21 · Biofire Diagnostics - Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138 (30…
FDA Device · Class II · 2026-10-21 · Biofire Diagnostics - BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
FDA Device · Class II · 2026-08-19 · Biofire Diagnostics - BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit
FDA Device · Class II · 2026-05-13 · Biofire Diagnostics
All Biofire Diagnostics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2683-2024%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.