| BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multip recall (Z-2936-2026) | BioFire Diagnostics, LLC | 2026-08-12 |
| BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit. recall (Z-2067-2026) | BioFire Diagnostics, LLC | 2026-05-06 |
| Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485 recall (Z-2081-2026) | BioFire Diagnostics, LLC | 2026-05-06 |
| BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit) recall (Z-0602-2026) | BioFire Diagnostics, LLC | 2025-11-26 |
| BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems recall (Z-1877-2025) | BioFire Diagnostics, LLC | 2025-05-29 |
| FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374 recall (Z-1518-2025) | BioFire Diagnostics, LLC | 2025-04-04 |
| FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Modu recall (Z-2588-2023) | BioFire Diagnostics, LLC | 2024-09-30 |
| FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W recall (Z-3122-2024) | BioFire Diagnostics, LLC | 2024-09-11 |
| FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U recall (Z-3123-2024) | BioFire Diagnostics, LLC | 2024-09-11 |
| BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144 recall (Z-2682-2024) | BioFire Diagnostics, LLC | 2024-08-16 |
| BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143 recall (Z-2683-2024) | BioFire Diagnostics, LLC | 2024-08-16 |
| BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILM recall (Z-2514-2024) | BioFire Diagnostics, LLC | 2024-08-06 |
| BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Sy recall (Z-2456-2024) | BioFire Diagnostics, LLC | 2024-07-31 |
| BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaer recall (Z-1139-2024) | BioFire Diagnostics, LLC | 2024-02-15 |
| FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test ki recall (Z-1140-2024) | BioFire Diagnostics, LLC | 2024-02-15 |
| FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (3 recall (Z-0993-2024) | BioFire Diagnostics, LLC | 2024-02-06 |
| FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit recall (Z-0994-2024) | BioFire Diagnostics, LLC | 2024-02-06 |
| BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-ba recall (Z-0703-2024) | BioFire Diagnostics, LLC | 2024-01-10 |
| The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test int recall (Z-0704-2024) | BioFire Diagnostics, LLC | 2024-01-10 |
| BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine recall (Z-0451-2024) | BioFire Diagnostics, LLC | 2023-12-01 |
| FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes recall (Z-0353-2024) | BioFire Diagnostics, LLC | 2023-11-20 |
| BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only recall (Z-2439-2023) | BioFire Diagnostics, LLC | 2023-08-21 |
| FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IV recall (Z-2440-2023) | BioFire Diagnostics, LLC | 2023-08-21 |
| FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouch recall (Z-1392-2023) | BioFire Diagnostics, LLC | 2023-04-14 |
| In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147 recall (Z-1251-2023) | BioFire Diagnostics, LLC | 2023-03-15 |
| In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742 recall (Z-1252-2023) | BioFire Diagnostics, LLC | 2023-03-15 |
| In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116 recall (Z-1253-2023) | BioFire Diagnostics, LLC | 2023-03-15 |
| FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Pan recall (Z-0296-2019) | BioFire Diagnostics, LLC | 2018-10-30 |
| FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 ( recall (Z-1513-2018) | BioFire Diagnostics, LLC | 2018-04-25 |