FilmArray® 2.0 Instrument FLM2-ASY-0001Recalls & reported problems
Biofire Diagnostics, LLC · IVD Instrument (FilmArray® 2.0 Instrument). · Class 2
All models of FilmArray 2.0 Instrument (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815381020031), 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 this device's 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- 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-3122-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- False Negative Result2
- Failure to Seal1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, 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 ↗
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- FilmArray® Torch System Base HTFA-ASY-0104Biofire Diagnostics, LLC · Instrumentation For Clinical Multiplex Test Systems1 recall4 reports
- FilmArray® 2.0 Instrument FLM2-ASY-0001-WBiofire Diagnostics, LLC · Instrumentation For Clinical Multiplex Test Systems1 recall0 reports
- FilmArray® Torch Module HTFA-ASY-0003-WBiofire Diagnostics, LLC · Instrumentation For Clinical Multiplex Test Systems1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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