FilmArray 2.0 InstrumentRecalls & reported problems across all models
Biofire Diagnostics, LLC · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one FilmArray 2.0 Instrument model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of FilmArray 2.0 Instrument by Biofire Diagnostics, LLC in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Jun 10, 2024 and Feb 13, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (2 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 2.0 Instrument 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, 2024Open, 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-3122-2024 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
Most reported FilmArray 2.0 Instrument problems
Device problems
- False Negative Result2
- Failure to Seal1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
FilmArray 2.0 Instrument models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- FilmArray® 2.0 Instrument FLM2-ASY-0001Instrumentation For Clinical Multiplex Test Systems1 recall3 reports
- FilmArray® 2.0 Instrument FLM2-ASY-0001-WInstrumentation For Clinical Multiplex Test Systems1 recall0 reports
Recent FilmArray 2.0 Instrument adverse event reports
The 3 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 13, 2025False Negative Result; False Negative Result
SUMMARY: OSPEDALE CA' FONCELLO TREVISO (TREVISO, ITALY) REPORTED A POTENTIAL FALSE NEGATIVE VERONA INTEGRON-ENCODED METALLO-BETA-LACTAMASE (VIM) RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION (BCID2) PANEL AFTER TESTING A PATIENT SAMPLE. THE PATIENT WAS NOT IMPACTED DUE TO THE BIOFIRE BCID2 PANEL RESULT. THE INVESTIGATION CONCLUDED THAT THE MOSTLY LIKELY CAUSE FOR THE DISCREPANT VIM RESULT WAS FILMARRAY 2.0 INSTRUMENT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21380591 ↗MalfunctionFeb 13, 2025False Negative Result; False Negative Result
SUMMARY: OSPEDALE CA' FONCELLO TREVISO (TREVISO, ITALY) REPORTED A POTENTIAL FALSE NEGATIVE PSEUDOMONAS AERUGINOSA RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION (BCID2) PANEL AFTER TESTING A PATIENT SAMPLE. THE PATIENT WAS NOT IMPACTED DUE TO THE BIOFIRE BCID2 PANEL RESULT. THE INVESTIGATION CONCLUDED THAT THE MOSTLY LIKELY CAUSE FOR THE DISCREPANT P. AERUGINOSA RESULT WAS FILMARRAY 2.0 INSTRUMENT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21380536 ↗MalfunctionJun 10, 2024Failure to Seal; Failure to Seal
SUMMARY: (B)(6) REPORTED A POTENTIAL FALSE NEGATIVE NEISSERIA MENINGITIDIS RESULT ON FILMARRAY MENINGITIS/ENCEPHALITIS (ME) PANEL AFTER TESTING A PATIENT'S CEREBROSPINAL FLUID (CSF). DUE TO THE FILMARRAY ME PANEL RESULT, THE PATIENT'S TREATMENT WAS DELAYED. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE FOR THE DISCREPANT RESULT WAS INSTRUMENT ERROR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19498946 ↗
Other Biofire Diagnostics, LLC products
- FilmArray Gastrointestinal (GI) Panel2 models · 24 reports · 6 recalls
- FilmArray Pneumonia Panel (Pneumo)2 models · 7 reports · 5 recalls
- FilmArray BCID Panel2 models · 5 reports · 2 recalls
- FilmArray Torch Module2 models · 25 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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