FDA Device recall Z-1877-2025
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
- FDA Device
- Class II
- ongoing
- Published 2025-06-04
On 2025-06-04 the FDA classified a Class II recall of BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems by Biofire Diagnostics, citing due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1877-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-30 |
| Published | 2025-06-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Biofire Diagnostics |
| Distribution | n/a |
Product
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
Reason
Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
Identifiers
| code_info | Lot# 1475424/ UDI: None |
|---|
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-1877-2025%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.