BioFire Diagnostics, LLC: 18 recalls on record

Recalls filed with 1 agency: FDA (18).

First recall on record: April 24, 2019. Most recent: August 19, 2026.

Risk classification: Class II: 18

Most recent recalls

DateAgencyProduct
August 19, 2026FDABIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based m…Z-2936-2026
May 13, 2026FDABioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.Z-2067-2026
May 13, 2026FDABiofire Spotfire Respiratory/Sore Throat Panel REF: 423485Z-2081-2026
June 4, 2025FDABioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systemsZ-1877-2025
September 18, 2024FDAFILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-WZ-3122-2024
September 18, 2024FDAFILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003UZ-3123-2024
August 28, 2024FDABIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144Z-2682-2024
August 28, 2024FDABIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143Z-2683-2024
August 14, 2024FDABIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE…Z-2514-2024
August 7, 2024FDABIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY S…Z-2456-2024
February 21, 2024FDABIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic …Z-1139-2024
February 21, 2024FDAFilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test…Z-1140-2024
February 14, 2024FDAFilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test ki…Z-0994-2024
February 14, 2024FDAFilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (…Z-0993-2024
January 17, 2024FDAThe BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test in…Z-0704-2024
January 17, 2024FDABIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-b…Z-0703-2024
June 17, 2020FDAFilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used wit…Z-2295-2020
April 24, 2019FDAFilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-AS…Z-1133-2019

Questions about this company

How many recalls does BioFire Diagnostics, LLC have?
Recalert has 18 U.S. recalls on record for BioFire Diagnostics, LLC, published between April 24, 2019 and August 19, 2026.
What was the most recent BioFire Diagnostics, LLC recall?
FDA recall Z-2936-2026, published August 19, 2026: BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
Which agencies have handled BioFire Diagnostics, LLC recalls?
BioFire Diagnostics, LLC appears as the recalling firm in recalls from: FDA (18).

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