BioFire Diagnostics, LLC Recalls

All product recalls associated with BioFire Diagnostics, LLC.

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Recall Summary

Total Recalls

21

Past Year

3

Class I (Serious)

0

Most Recent

Oct 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 21 recalls

BioFire Respiratory Panel 2.1 (BioFire) – False Negative Risk (2025)

Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.

Moderate

FDAOct 22, 2025Nationwide• BioFire Diagnostics, LLC

BioFire Respiratory Panel (BioFire) – Test Result Errors (2025)

Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.

Moderate

FDAApr 30, 2025IN• BioFire Diagnostics, LLC

FilmArra Pneumonia Panel (BioFire) – Test Result Reliability (2025)

Increased risk of control failures and false negative test results with multiplexed nucleic acid test.

Moderate

FDAFeb 27, 2025Nationwide

• BioFire Diagnostics, LLC

BioFire Diagnostics, LLC: FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-...

Salmonella

Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting temperatures, which may lead to erroneous results including false positive Salmonella, Giardia lamblia, false positive/negative Norovirus, and false negative MRSA.

Moderate

FDAAug 7, 2024Nationwide• BioFire Diagnostics, LLC

BioFire Diagnostics, LLC: FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-00...

Salmonella

Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting temperatures, which may lead to erroneous results including false positive Salmonella, Giardia lamblia, false positive/negative Norovirus, and false negative MRSA.

Moderate

FDAAug 7, 2024Nationwide• BioFire Diagnostics, LLC

BioFire Diagnostics, LLC: BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF...

If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an increased level of non-viable organism from serratia marcescens targets in culture media bottles, false positive result may lead to an inappropriate change in patient therapy.

Moderate

FDAJun 19, 2024Nationwide• BioFire Diagnostics, LLC

BioFire Diagnostics, LLC: BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144

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.

Moderate

FDAJun 10, 2024Nationwide• BioFire Diagnostics, LLC

BioFire Diagnostics, LLC: BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-AS...

Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.

Moderate

FDAMay 16, 2024Nationwide• BioFire Diagnostics, LLC

BioFire Diagnostics, LLC: BIOFIRE Blood Culture Identification 2 (BCID2) Panel whe...

Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums

Moderate

FDAJan 26, 2024Nationwide• BioFire Diagnostics, LLC

BioFire Diagnostics, LLC: FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 t...

Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.

Moderate

FDAJan 26, 2024Nationwide• BioFire Diagnostics, LLC

BioFire Diagnostics, LLC: FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CE...

Their is a potential for false positive results when using Pneumonia panel.

Moderate

FDADec 14, 2023Nationwide• BioFire Diagnostics, LLC

BioFire Diagnostics, LLC: FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-AS...

Their is a potential for false positive results when using Pneumonia panel.

Moderate

FDADec 14, 2023Nationwide• BioFire Diagnostics, LLC

BioFire Diagnostics, LLC: BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualit...

A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.

Moderate

FDANov 27, 2023CA, CT, FL +13 more• BioFire Diagnostics, LLC

BioFire Diagnostics, LLC: The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based ...

A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.

Moderate

FDANov 27, 2023CA, CT, FL +13 more• BioFire Diagnostics, LLC

BioFire Diagnostics, LLC: BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF...

Routine quality control testing of affected blood culture identification panel with affected control panel may need to be amended, due to control panel/instrument characteristic changes, that lead C. tropicalis to be amplified in some portion of test runs, but then it's reported as "Not Detected" because the assay amplicon Tm is outside the acceptable limit assigned for calling positive results.

Moderate

FDAOct 17, 2023Nationwide• BioFire Diagnostics, LLC

BioFire Diagnostics, LLC: FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the ...

Due to an increased risk of degradation of the power entry switch resulting from arcing inside of the power switch that may result in carbon build-up on the switch contacts. The carbon build-up may lead to excess heating inside of the power switch, subsequently leading to deformation of the power switch case. The deformation can create an opportunity for a power switch electrical short. In addition to an electrical short, deformation may result in an open circuit causing the power switch to fail. This event would only occur after the product is in use.

Moderate

FDAOct 17, 2023Nationwide• BioFire Diagnostics, LLC

BioFire Diagnostics, LLC: BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For F...

Due to manufacturing issue, panels may result in false negative results.

Moderate

FDAMay 8, 2023CA, CO, CT +21 more• BioFire Diagnostics, LLC

BioFire Diagnostics, LLC: FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, F...

Due to manufacturing issue, panels may result in false negative results.

Moderate

FDAMay 8, 2023CA, CO, CT +21 more• BioFire Diagnostics, LLC

BioFire Diagnostics, LLC: FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY...

Fire/Burn Risk

The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel

High

FDAApr 25, 2023AL, AK, AZ +49 more• BioFire Diagnostics, LLC

BioFire Diagnostics, LLC: FilmArray Gastrointestinal (GI) Panel for FILMARRAY Syste...

Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.

Moderate

FDAMar 8, 2023Nationwide• BioFire Diagnostics, LLC

Stay Informed

BioFire Diagnostics, LLC Recalls

Recall Summary

BioFire Respiratory Panel 2.1 (BioFire) – False Negative Risk (2025)

BioFire Respiratory Panel (BioFire) – Test Result Errors (2025)

FilmArra Pneumonia Panel (BioFire) – Test Result Reliability (2025)

BioFire Diagnostics, LLC: FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-...

BioFire Diagnostics, LLC: FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-00...

BioFire Diagnostics, LLC: BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF...

BioFire Diagnostics, LLC: BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144

BioFire Diagnostics, LLC: BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-AS...

BioFire Diagnostics, LLC: BIOFIRE Blood Culture Identification 2 (BCID2) Panel whe...

BioFire Diagnostics, LLC: FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 t...

BioFire Diagnostics, LLC: FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CE...

BioFire Diagnostics, LLC: FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-AS...

BioFire Diagnostics, LLC: BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualit...

BioFire Diagnostics, LLC: The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based ...

BioFire Diagnostics, LLC: BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF...

BioFire Diagnostics, LLC: FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the ...

BioFire Diagnostics, LLC: BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For F...

BioFire Diagnostics, LLC: FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, F...

BioFire Diagnostics, LLC: FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY...

BioFire Diagnostics, LLC: FilmArray Gastrointestinal (GI) Panel for FILMARRAY Syste...