FDA Device recall Z-2682-2024
BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
- 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, REF: RFIT-ASY-0144 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-2682-2024 |
| 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, REF: RFIT-ASY-0144
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: 00815381020178. Lot/Expiration: 2147623/28-Aug-2024, 2147523/27-Aug-2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2682-2024%22
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