BioFire Diagnostics, LLC recalls
Every recall we track for BioFire Diagnostics, LLC — 46 in all, from 2018–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from BioFire Diagnostics, LLC fell by more than half in 2025 (3, down from 8 in 2024).
All FDA recall records for BioFire Diagnostics, LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 3 | 0 | 3 |
| 2019 | 0 | 0 | 3 | 0 | 3 |
| 2020 | 0 | 0 | 2 | 0 | 2 |
| 2021 | 0 | 0 | 8 | 0 | 8 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 1 | 12 | 0 | 13 |
| 2024 | 0 | 0 | 8 | 0 | 8 |
| 2025 | 0 | 0 | 3 | 0 | 3 |
| 2026 (to date) | 0 | 0 | 4 | 2 | 6 |
Most common reasons for BioFire Diagnostics, LLC recalls
What to do if you have a recalled BioFire Diagnostics, LLC product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All BioFire Diagnostics, LLC recalls
34 shown- Lower riskMedical device
BioFire Diagnostics, LLC recalls Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog
BioFire Diagnostics recalls specific joint infection test kits that may produce false positive results due to contaminated components. Affected kits include model RFIT-ASY-0138 (30 kits) and RFIT-ASY-0135 (6 kits) with certain lot numbers.
BioFire DiagnosticsAug 12, 2026 - Lower riskMedical device
BioFire Diagnostics, LLC recalls BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in
BioFire recalls Respiratory Panel 2.1 (RP2.1) REF 423742 due to increased false negative results in PCR tests. Affected units have UDI code 00815381020529.
BioFireJun 24, 2026 - Lower riskMedical device
BioFire Diagnostics, LLC recalls BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
BioFire recalls 30-test Joint Infection Panel REF: RFIT-ASY-0138 due to contamination risk causing false positives in diagnostic tests. Affected units include specific lot numbers.
BioFireApr 22, 2026 - Lower riskMedical device
BioFire Diagnostics, LLC recalls Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
BioFire recalls respiratory/sore throat test panels with risk of false negatives and control failures. Affected units include REF: 42348: 2215125 lot numbers.
BioFireApr 1, 2026 - Lower riskMedical device
BioFire Diagnostics, LLC recalls BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
BioFire Diagnostics recalls Respiratory Panel 2.1 kits due to false negative results and control failures from pouch chemistry movement. Affected kits have specific UDI and lot numbers.
BioFireOct 22, 2025 - Lower riskMedical device
BioFire Diagnostics, LLC recalls BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
BioFire Diagnostics recalls Respiratory Panel 2.1 plus Kit (REF: 423740) for possible false negative results from manufacturing errors. Affected units may need replacement.
BioFireApr 30, 2025 - Lower riskMedical device
BioFire Diagnostics, LLC recalls FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
BioFire Diagnostics recalls Pneumoplus pneumonia test panels due to increased risk of false negatives from control failures. Affected units have specific UDI and lot numbers.
BioFire DiagnosticsFeb 27, 2025 - Lower riskMedical device
BioFire Diagnostics, LLC recalls FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
BioFire Diagnostics recalls FILMARRAY 2.0 instruments from May 2022-May 2024 that may report false positive Salmonella, Giardia, and Norovirus results due to calibration issues.
BioFire DiagnosticsAug 7, 2024 - Lower riskMedical device
BioFire Diagnostics, LLC recalls BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in
BioFire recalls BCID2 Blood Culture Panel for FILMARRAY Systems when used with specific culture media lots. False positive Serratia marcescens results may lead to incorrect patient treatment.
BioFireJun 19, 2024 - Lower riskMedical device
BioFire Diagnostics, LLC recalls BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
BioFire Diagnostics recalls its Pneumonia Panel Plus due to potential delayed test results from manufacturing control failures. Affected units have specific lot numbers and expiration dates.
BioFire DiagnosticsJun 10, 2024 - Lower riskMedical device
BioFire Diagnostics, LLC recalls BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI)
BioFire Diagnostics recalls GI test kits that may give false positive Vibrio results when used with Remel Cary Blair transport medium. Affected kits include RFIT-ASY-0116 (30 tests) and RFIT-ASY-0104 (6 tests).
BioFireMay 16, 2024 - Lower riskMedical device
BioFire Diagnostics, LLC recalls BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds
BioFire Diagnostics recalls BCID2 Blood Culture Panel when used with specific BD BACTEC vials due to false positive Candida tropicalis results. Affected units may show incorrect fungal detection.
BioFire DiagnosticsJan 26, 2024 - Lower riskMedical device
BioFire Diagnostics, LLC recalls FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal
BioFire Diagnostics recalls GI panels with potential for false positive Norovirus results. Affected kits include RFIT-ASY-0116 (30 tests) and RFIT-ASY-0104 (6 tests).
BioFire DiagnosticsJan 26, 2024 - Lower riskMedical device
BioFire Diagnostics, LLC recalls FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)
BioFire Diagnostics recalls Pneumonia Panel Plus (Pneumoplus) kits due to potential false positive results. Affected kits include all unexpired lots with UDI 00815381020314.
BioFire DiagnosticsDec 14, 2023 - Lower riskMedical device
BioFire Diagnostics, LLC recalls The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the
BioFire recalls Respiratory Panel 2.1 kits that may give false negative results, risking incorrect antibiotic use or delayed treatment for infections.
BioFireNov 27, 2023 - Use cautionMedical device
BioFire Diagnostics, LLC recalls FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen
BioFire recalls Torch Base (HTFA-ASY-0104) due to increased risk of power switch degradation causing potential short circuits or failure. Affected units have serial numbers listed in the recall notice.
BioFireOct 17, 2023 - Lower riskMedical device
BioFire Diagnostics, LLC recalls BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls,
BioFire Diagnostics recalls BCID2 Blood Culture Panel REF RFIT-ASY-0147 with Maine Molecular Quality Controls control panels. Affected units may show C. tropicalis as 'Not Detected' due to assay errors. Contact for remedy.
BioFireOct 17, 2023 - Lower riskMedical device
BioFire Diagnostics, LLC recalls BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
BioFire Diagnostics recalls Respiratory Panel 2.1 (RP2.1) with REF 423742 due to potential false negative results. Affected units have specific lot numbers and expiration dates.
BioFireMay 8, 2023 - Lower riskMedical device
BioFire Diagnostics, LLC recalls FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
BioFire recalls FILMARRAY GI Panel software versions before FLM2-SFW-0040 v2.0.3.1 that may cause false positive Cryptosporidium results. Affected units include specific model numbers and serial ranges.
BioFireApr 25, 2023 - Lower riskMedical device
BioFire Diagnostics, LLC recalls FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
BioFire Diagnostics recalls FilmArray GI Panel kits with possible false negative results due to manufacturing issues. Affected kits include specific lot numbers and model.
BioFire DiagnosticsMar 8, 2023 - Lower riskMedical device
BioFire Diagnostics, LLC recalls In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147
BioFire Diagnostics recalls BCID2 IVD Panel due to temperature excursions during shipping delays that may reduce performance. Affected units include specific lot numbers and model.
BioFire DiagnosticsFeb 1, 2023 - Lower riskMedical device
BioFire Diagnostics, LLC recalls BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog
BioFire recalls BCID2 blood culture panels with possible false Acinetobacter calcoaceticus-baumannii complex results due to non-viable contamination in vials. Affected panels expire by April 30, 2022.
BioFireOct 11, 2021 - Lower riskMedical device
BioFire Diagnostics, LLC recalls FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126
BioFire Diagnostics recalls FilmArray BCID Panel product pouches with part numbers RFIT-ASY-0126/0127 that may cause false negative blood culture results due to manufacturing errors.
BioFire DiagnosticsJul 20, 2021 - Lower riskMedical device
BioFire Diagnostics, LLC recalls FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No:
BioFire Diagnostics recalls pneumonia test kits that may give false negative results after 6 months of use. Affected kits have specific part numbers and serial codes. Stop using if expired.
BioFire DiagnosticsJun 7, 2021 - Lower riskMedical device
BioFire Diagnostics, LLC recalls BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro
BioFire recalls BCID2 Panel (REF RFIT-ASY-0147) due to potential false negatives in blood culture tests. Affected units have pouches with wrong packaging material. Contact for remedy.
BioFireMay 10, 2021 - Lower riskMedical device
BioFire Diagnostics, LLC recalls FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
BioFire Diagnostics recalls Pneumonia Panel (Penumo) REF RFIT-ASY-014: elevated false positives/negatives and control failures due to manufacturing issues. Affected units include specific lot numbers and model.
BioFire DiagnosticsApr 16, 2021 - Lower riskMedical device
BioFire Diagnostics, LLC recalls Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array
BioFire Diagnostics recalls Gram-Negative Bacteria Blood Culture Panels that may give false Pseudomonas aeruginosa results when used with certain BD BACTEC vials. Affected units include specific model numbers and lots.
BioFireJan 26, 2021 - Lower riskMedical device
BioFire Diagnostics, LLC recalls FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used with the following BACT/ALERT Blood
BioFire recalls FilmArray BCID Panel (RFIT-ASY-0126) used with specific BACT/ALERT blood culture bottles. False positive Proteus results may cause improper antibiotic treatment. Affected units have UDI: 00815381020086.
BioFireJan 22, 2020 - Lower riskMedical device
BioFire Diagnostics, LLC recalls FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
BioFire Diagnostics recalls GI Panel kits with false negative results that could lead to incorrect treatment and serious health issues. Affected kits have specific UDI and expiration dates.
BioFire DiagnosticsAug 8, 2019 - Lower riskMedical device
BioFire Diagnostics, LLC recalls FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the
BioFire Diagnostics recalls FilmArray BCID Panels that may cause false positive results for Enterobacteriaceae and E. coli when used with specific blood culture bottles. Affected units include certain model numbers and lots.
BioFire DiagnosticsMar 7, 2019 - Lower riskMedical device
BioFire Diagnostics, LLC recalls FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116),
BioFire Diagnostics recalls GI Panel devices due to elevated false positives for Campylobacter and Cryptosporidium. Affected units have expiration dates from October 2019 onward. No remedy specified in recall notice.
BioFire DiagnosticsMar 6, 2019 - Lower riskMedical device
BioFire Diagnostics, LLC recalls -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray
BioFire Diagnostics recalls specific FilmArray Meningitis/Encephalitis panels due to potential false positives for HSV-1. Affected kits may require replacement to avoid incorrect test results.
BioFire DiagnosticsSep 10, 2018 - Lower riskMedical device
BioFire Diagnostics, LLC recalls FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI:
BioFire Diagnostics recalls FilmArray Blood Culture Identification kits that may give false positive results for Proteus when used with certain blood culture bottles. Affected kits include specific catalog numbers and bottle types.
BioFire DiagnosticsSep 5, 2018 - Lower riskMedical device
BioFire Diagnostics, LLC recalls FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and
BioFire Diagnostics recalls FilmArray BCID Blood Culture Panels with specific BD BACTEC bottles, risking false Proteus results. Affected units include catalog numbers RFIT-ASY-0126 and RFIT-ASY-0127 with certain bottle lots.
BioFire DiagnosticsMar 14, 2018
BioFire Diagnostics, LLC recall questions
How many recalls has BioFire Diagnostics, LLC had?
46 recalls from BioFire Diagnostics, LLC are on record with U.S. safety agencies, from 2018–2026.
What is the most recent BioFire Diagnostics, LLC recall?
BioFire Diagnostics, LLC recalls Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog, dated Aug 12, 2026. Every BioFire Diagnostics, LLC recall is listed on this page, newest first.
Why are BioFire Diagnostics, LLC products recalled?
The most common reasons on record: Due to manufacturing issue, panels may result in false negative results. (2); Their is a potential for false positive results when using Pneumonia panel. (2).
What should I do if I have a recalled BioFire Diagnostics, LLC product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new BioFire Diagnostics, LLC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.