RecallHawk

BioFire Diagnostics, LLC

41 FDA actions

BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.

BioFire Diagnostics, LLC

Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485

BioFire Diagnostics, LLC

BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)

BioFire Diagnostics, LLC

BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini

Biofire Diagnostics, LLC

BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems

BioFire Diagnostics, LLC

FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374

BioFire Diagnostics, LLC

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid

Biofire Diagnostics, LLC

BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))

Biofire Diagnostics, LLC

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel

Biofire Diagnostics, LLC

FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W

BioFire Diagnostics, LLC

FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U

BioFire Diagnostics, LLC

BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143

BioFire Diagnostics, LLC

BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144

BioFire Diagnostics, LLC

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI

BioFire Diagnostics, LLC

BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunctio

BioFire Diagnostics, LLC

BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini

Biofire Diagnostics, LLC

BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel

Biofire Diagnostics, LLC

FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal micro

BioFire Diagnostics, LLC

BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Ped

BioFire Diagnostics, LLC

FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)

BioFire Diagnostics, LLC

FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)

BioFire Diagnostics, LLC

The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE

BioFire Diagnostics, LLC

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test i

BioFire Diagnostics, LLC

BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, In

BioFire Diagnostics, LLC

FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen

BioFire Diagnostics, LLC

FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software

BioFire Diagnostics, LLC

BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only

BioFire Diagnostics, LLC

FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only

BioFire Diagnostics, LLC

FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)

BioFire Diagnostics, LLC

BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini

Biofire Diagnostics, LLC

In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147

BioFire Diagnostics, LLC

In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742

BioFire Diagnostics, LLC

In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116

BioFire Diagnostics, LLC

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel

Biofire Diagnostics, LLC

FilmArray Pneumonia Panel plus

Biofire Diagnostics, LLC

BioFire Joint Infection (JI) Panel

Biofire Diagnostics, LLC

BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog N

BioFire Diagnostics, LLC

FilmArray Pneumonia Panel

Biofire Diagnostics, LLC

FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0

BioFire Diagnostics, LLC

FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No

BioFire Diagnostics, LLC

FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit)

BioFire Diagnostics, LLC