FilmArray Torch ModuleRecalls & reported problems across all models
Biofire Diagnostics, LLC · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one FilmArray Torch Module model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of FilmArray Torch Module by Biofire Diagnostics, LLC in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Oct 10, 2024 and Sep 10, 2026 — classified as 25 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (15 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
FilmArray Torch Module recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 7, 2024Class IIOpen, Classified
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.
Z-3123-2024 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
Most reported FilmArray Torch Module problems
Device problems
- False Negative Result15
- False Positive Result10
- No Apparent Adverse Event3
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- Insufficient Information11
FilmArray Torch Module models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- FilmArray® Torch Module HTFA-SUB-0103Instrumentation For Clinical Multiplex Test Systems1 recall25 reports
- FilmArray® Torch Module HTFA-ASY-0003-WInstrumentation For Clinical Multiplex Test Systems1 recall0 reports
Recent FilmArray Torch Module adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714690 ↗MalfunctionSep 10, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714671 ↗MalfunctionAug 26, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50450088 ↗MalfunctionAug 26, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50449986 ↗MalfunctionAug 26, 2026False Positive Result
(b)(6) Hospital ((b)(6) MD) reported potential false positive Coronavirus HKU1 and Parainfluenza virus 4 results on FilmArray® Torch Module (b)(6) after testing the patient¿s nasopharyngeal (NP) sample with the BioFire® Respiratory Panel 2.1 Panel. No patient harm was reported. A potential product malfunction was identified. Torch Module (b)(6) was returned for the investigation. BioFire has requested further information from the customer and is currently investigating this event. No remedial action, corrective action, preventive action, or field safety corrective action (FSCA) has been deemed necessary at this time.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50449976 ↗MalfunctionAug 26, 2026False Positive Result
(b)(6) reported a potential false positive Parainfluenza virus 4 result on FilmArray® Torch Module TM25540 after testing the patient¿s bronchoalveolar lavage (BAL) sample with the BioFire® Respiratory Panel 2.1 Panel. No patient harm was reported. A potential product malfunction was identified. Torch Module TM25540 was returned for the investigation. BioFire has requested further information from the customer and is currently investigating this event. No remedial action, corrective action, preventive action, or field safety corrective action (FSCA) has been deemed necessary at this time.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50449971 ↗MalfunctionAug 26, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50449969 ↗MalfunctionAug 26, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50449890 ↗MalfunctionAug 26, 2026False Positive Result
(b)(6) reported potential false positive Human metapneumovirus, Influenza A H1, and Parainfluenza virus 4 results on FilmArray® Torch Module (b)(6) after testing the patient¿s nasopharyngeal (NP) sample with the BioFire® Respiratory Panel 2.1 Panel. No patient harm was reported. A potential product malfunction was identified. Torch Module (b)(6) was returned for the investigation. BioFire has requested further information from the customer and is currently investigating this event. No remedial action, corrective action, preventive action, or field safety corrective action (FSCA) has been deemed necessary at this time.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50449879 ↗MalfunctionApr 30, 2026False Positive Result
(B)(6) ((B)(6), FRANCE) REPORTED A POTENTIAL FALSE-POSITIVE NEISSERIA MENINGITIDIS RESULT ON THE FILMARRAY® MENINGITIS/ENCEPHALITIS (ME) PANEL AFTER TESTING A PATIENT CSF SAMPLE. THE CUSTOMER REPORTED THAT DUE TO THE ME PANEL THE PATIENT WAS AFFECTED DUE TO PROLONGED TREATMENT (INAPPROPRIATE TREATMENT). NO PATIENT HARM WAS REPORTED. A POTENTIAL PRODUCT MALFUNCTION WAS IDENTIFIED. THE INVESTIGATION FOUND THAT THE MOST LIKELY CAUSE OF THE DISCREPANT RESULT WAS A POSSIBLE INSTRUMENT ERROR OR POUCH ERROR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25044907 ↗MalfunctionSep 24, 2025False Negative Result; False Negative Result
SUMMARY: (B)(6) REPORTED A POTENTIAL FALSE NEGATIVE RESULTS ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL RUNS ON THE FILMARRAY TORCH MODULE (B)(6). NO PATIENT HARM WAS REPORTED. THE INVESTIGATION DETERMINED THAT THE MOST PROBABLE CAUSE OF THE DISCREPANT RESULT WAS A PATIENT LABEL BECOMING DISLODGED WITHIN THE FILMARRAY TORCH MODULE, OBSTRUCTING THE CAMERA.
Patient problems: Insufficient Information
MAUDE report 23137225 ↗MalfunctionSep 19, 2025False Negative Result; False Negative Result
SUMMARY: MISSION REGIONAL MEDICAL CENTER (MISSION, TX) REPORTED POTENTIAL FALSE NEGATIVE STAPHYLOCOCCUS AUREUS RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL RUN ON THE FILMARRAY TORCH MODULE (B)(6). THE PATIENT'S RESULT WAS DELAYED DUE TO THE DISCREPANT RESULT. A MALFUNCTION OF THE FILMARRAY TORCH INSTRUMENT (B)(6) IS SUSPECTED. A FINAL REPORT WITH ALL INVESTIGATION DETAILS WILL BE PROVIDED. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FIELD SAFETY CORRECTIVE ACTION (FSCA) HAS BEEN DEEMED NECESSARY AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23103295 ↗MalfunctionSep 19, 2025False Negative Result; False Negative Result
SUMMARY: (B)(6) REPORTED A POTENTIAL FALSE NEGATIVE STAPHYLOCOCCUS AUREUS RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL RUN ON THE FILMARRAY TORCH MODULE (B)(6). THE PATIENT WAS NOT IMPACTED DUE TO THE DISCREPANT RESULT. BASED ON THE INFORMATION PROVIDED, AND INTERNAL TESTING ON THE INSTRUMENT, THE INVESTIGATION CONCLUDED THE MOST LIKELY CAUSE FOR THE REPORTED DISCREPANCY WAS DUE TO A FILMARRAY TORCH MODULE ERROR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23103294 ↗MalfunctionSep 19, 2025False Negative Result; False Negative Result
SUMMARY: (B)(6) REPORTED POTENTIAL FALSE NEGATIVE METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL. THE PATIENT'S APPROPRIATE TREATMENT WAS DELAYED DUE TO THE DISCREPANT RESULT. THE INVESTIGATION CONCLUDED THAT THE MOST PROBABLE CAUSE OF THE DISCREPANT MRSA RESULTS ON THE BIOFIRE BCID2 PANEL WAS THE PRESENCE OF AN MREJ STRAIN EXHIBITING REDUCED REACTIVITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23103293 ↗MalfunctionSep 17, 2025False Negative Result; False Negative Result
SUMMARY: (B)(6) HOSPITAL (B)(6) JAPAN) REPORTED A POTENTIAL FALSE NEGATIVE ACINETOBACTER CALCOACETICUS-BAUMANNII (ACB) COMPLEX RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL RUN ON THE FILMARRAY TORCH MODULE AFTER TESTING A PATIENT'S BLOOD CULTURE SAMPLE. IT IS UNKNOWN IF THERE WAS IMPACT TO THE PATIENT DUE TO THE BIOFIRE BCID2 PANEL RESULT. THE INVESTIGATION CONCLUDED THAT THE CAUSE OF THE DISCREPANCY WAS FILMARRAY TORCH MODULE (B)(6) ISSUE DUE TO A DELAMINATED WINDOW BLADDER THAT AFFECTED INSTRUMENT PERFORMANCE.
Patient problems: Insufficient Information
MAUDE report 23079571 ↗
Other Biofire Diagnostics, LLC products
- FilmArray Gastrointestinal (GI) Panel2 models · 24 reports · 6 recalls
- FilmArray Pneumonia Panel (Pneumo)2 models · 7 reports · 6 recalls
- FilmArray Pneumonia Panel plus (Pneumoplus)2 models · 4 reports · 4 recalls
- BioFire Joint Infection (JI) Panel2 models · 6 reports · 2 recalls
- FilmArray BCID Panel2 models · 5 reports · 2 recalls
- FilmArray 2.0 Instrument2 models · 3 reports · 1 recall
- FilmArray Meningitis/Encephalitis (ME) Panel2 models · 32 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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