FilmArray Meningitis/Encephalitis (ME) PanelRecalls & reported problems across all models

We found 2 models of FilmArray Meningitis/Encephalitis (ME) Panel by Biofire Diagnostics, LLC in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Jan 12, 2017 and Sep 22, 2026 — classified as 8 deaths, 24 injuries.

The most frequently reported specific device problem is “False Positive Result” (18 reports).

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

Most reported FilmArray Meningitis/Encephalitis (ME) Panel problems

FilmArray Meningitis/Encephalitis (ME) Panel models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• FilmArray® Meningitis/Encephalitis (ME) Panel RFIT-ASY-0118

  Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
  6 deaths30 reports
• FilmArray® Meningitis/Encephalitis (ME) Panel RFIT-ASY-0119

  Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
  2 deaths2 reports

Recent FilmArray Meningitis/Encephalitis (ME) Panel adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026False Positive Result

  Summary: The customer (Muscat, Oman) reported a potential false positive Escherichia coli K1 (E. coli K1) result on the FilmArray® Meningitis/Encephalitis (ME) Panel after testing a patient CSF sample. The customer reported that due to the ME Panel result, the patient was indirectly impacted, specifically by inappropriate treatment, which might lead to serious injury if it were to recur. The customer stated that the patient was not harmed. 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 50854377 ↗
• InjurySep 10, 2026False Positive Result

  Summary:(b)(6) l "[Canada]" reported a potential false positive H. influenzae result on the FilmArray® Meningitis/Encephalitis (ME) Panel after testing a patient cerebrospinal fluid sample. The customer reported that due to the ME panel result, that patient was indirectly impacted, specifically through unnecessary antibiotic treatment, which might lead to serious injury if it were to recur. No patient harm was reported.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 50714236 ↗
• InjurySep 9, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50701517 ↗
• InjurySep 9, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50699610 ↗
• InjurySep 9, 2026False Positive Result

  Summary:(b)(6) "[France]" reported a potential false positive VZV result on the FilmArray® Meningitis/Encephalitis (ME) Panel after testing a patient cerebrospinal fluid sample. The customer reported that due to the ME panel result, that patient was indirectly impacted, specifically inappropriately treated with Acyclovir from (b)(6) 2026, which might lead to serious injury if it were to recur. No patient harm was reported.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 50689824 ↗
• InjurySep 4, 2026False Positive Result

  Summary:(b)(6) HOSP - (b)(6) USA) reported a false positive Varicella Zoster Virus (VZV) result on the FilmArray® Meningitis/Encephalitis (ME) Panel after testing a patient cerebrospinal fluid (CSF) sample from a 6 month old male patient. The customer reported that due to the ME Panel result, the patient was indirectly impacted, specifically inappropriate treatment with acyclovir, which might lead to serious injury if it were to recur. No patient harm was reported. 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 50614575 ↗
• InjurySep 2, 2026False Positive Result

  Summary:The customer (b)(6) reported a potential false positive Varicella zoster virus (VZV) result on the FilmArray® Meningitis/Encephalitis (ME) Panel after testing a patient CSF sample. The customer reported that due to the ME Panel result, that patient was indirectly impacted, specifically initiation of acyclovir that was likely unnecessary, which might lead to serious injury if it were to recur. No patient harm was reported.The investigation concluded that the most likely cause of the VZV discrepant result was due to low level contamination.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50570510 ↗
• InjuryAug 6, 2026False Negative Result

  Summary: The customer ((b)(6) Mexico) reported a potential false negative Cryptococcus neoformans/gattii (C. neoformans/gattii) result on the FilmArray® Meningitis/Encephalitis (ME) Panel after testing a CSF sample from an 85-year-old male patient. The customer reported that due to the ME Panel result, that patient was indirectly impacted, specifically by a delay in treatment of approximately one day, which might lead to serious injury if it were to recur. No patient harm was reported, however it was reported the patient later expired for reasons unrelated to the ME Panel result. The investigation concluded that the most likely cause for the discrepant Cryptococcus results was comparator sensitivity/specificity differences between the ME Panel and traditional laboratory methods.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161312 ↗
• InjuryAug 6, 2026False Positive Result

  Summary:The customer (Clamart, France) reported a potential false positive E. coli K1 result on the FilmArray® Meningitis/Encephalitis (ME) Panel after testing a CSF patient sample. The customer reported that due to the ME Panel result, that patient was indirectly impacted, specifically an escalation of intravenous antibiotic therapy, which might lead to serious injury if it were to recur. No patient harm was reported.The investigation concluded that the most likely cause of the false positive E. coli K1 result was contamination.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50157218 ↗
• InjuryAug 5, 2026False Negative Result

  Summary:The customer ((b)(6) Australia) reported a potential false negative Neisseria meningitidis (N. meningitidis) result on the FilmArray® Meningitis/Encephalitis (ME) Panel after testing a patient CSF sample. The customer reported that due to the ME Panel result, that patient was indirectly impacted, specifically delayed/interrupted treatment, which might lead to serious injury if it were to recur. Patient harm is unknown. Based on the information provided, the investigation concluded that the most likely cause of the erroneous N. meningitidis result was sensitivity/specificity differences between the ME Panel and comparator methods with a low-level analyte near the limit of detection (LoD) of the FilmArray system.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50145006 ↗
• InjuryAug 5, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50139323 ↗
• InjuryJul 31, 2026False Positive Result

  Summary:SPSK NR. 1 ((b)(6), Poland) reported a false positive S. agalactiae and HHV-6 result on the FilmArray® Meningitis/Encephalitis (ME) Panel after testing a patient cerebrospinal fluid (CSF) sample. Due to the ME Panel result, the patient may have received inappropriate treatment. No patient harm was reported. BioFire has requestedfurther 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 50105690 ↗
• InjuryJul 30, 2026False Positive Result

  Summary:The customer (Aalst, Belgium) reported a false-positive HSV-1 result on the FilmArray Meningitis/Encephalitis (ME) Panel after testing a patient CSF sample. The customer reported that due to the ME Panel result, the patient was treated inappropriately with acyclovir for two days. They subsequently stated that the patient suffered no other harm and did not deteriorate due to the erroneous BioFire result. The investigation concluded that the most likely causes of the potential false-positive result were low-level organism/nucleic acid present within the sample near the BIOFIRE Limit of Detection (LoD) or contamination.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50092758 ↗
• InjuryFeb 12, 2026False Negative Result

  (B)(6). PUBLISHED A STUDY, "(B)(6)" WHICH DESCRIBES A POTENTIAL FALSE NEGATIVE HSV-1 AND A POTENTIAL FALSE NEGATIVE HHV-6 ON THE FILMARRAY MENINGITIS/ENCEPHALITIS (ME) PANEL DURING TESTING OF A CSF SAMPLE FROM A 20-MONTH-OLD MALE PATIENT. THE PUBLICATION SUGGESTED THAT THE BIOFIRE RESULT LED TO PREMATURE DISCONTINUATION OF ACYCLOVIR, WHICH CONTRIBUTED TO NEUROLOGICAL SEQUELAE, INCLUDING SPASTIC QUADRIPARESIS AND FUNCTIONAL DEPENDENCE. BIOFIRE HAS REQUESTED FURTHER INFORMATION FROM THE AUTHOR 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. UPDATE FOR SUPPLEMENTAL REPORT: UPON FOLLOWING WITH THE AUTHORS, THEY INDICATED THE STUDY SAMPLE WAS FROM OVER A YEAR AGO. THE FIRST FILMARRAY RESULT WAS FROM ANOTHER CLIENT (FUNDACIÓN CLUB NOEL), BUT THE CHILD HAD BEEN EXPERIENCING SYMPTOMS FOR LESS THAN 24 HOURS, SO THE POSSIBILITY OF A FALSE NEGATIVE WAS VERY HIGH. THE PATIENT DID NOT REQUIRE ANY FURTHER INTERVENTION AND SUFFERED NO LASTING EFFECTS FROM DISCONTINUING THE TREATMENT. BIOFIRE IS STILL INVESTIGATING THIS EVENT IN ORDER TO DETERMINE THE ROOT CAUSE. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24325009 ↗
• DeathJan 16, 2026False Negative Result

  LEONG ET AL. PUBLISHED A STUDY "A LETHAL CASE OF CRYPTOCOCCAL MENINGITIS IN AN APPARENTLY IMMUNOCOMPETENT PATIENT: A CASE REPORT HIGHLIGHTING DIAGNOSTIC PITFALLS AND THERAPEUTIC CHALLENGES," WHICH DESCRIBES A POTENTIAL FALSE NEGATIVE CRYPTOCOCCUS NEOFORMANS/GATTII RESULT ON THE FILMARRAY MENINGITIS/ENCEPHALITIS (ME) PANEL DURING PATIENT TESTING. THE PUBLICATION SUGGESTED THAT THE BIOFIRE RESULT MAY HAVE DIRECTLY CONTRIBUTED TO A DELAY IN DIAGNOSIS. THE PUBLICATION FURTHER CLAIMED THAT THE DIAGNOSTIC DIFFICULTIES ENCOUNTERED WITH THIS PATIENT EVENTUALLY LEAD TO THE DELAYED DIAGNOSIS AND MORTALITY. THE AUTHORS WERE UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING PATIENT IMPACT. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE OF THE POTENTIAL FALSE NEGATIVE RESULT WAS LOW-LEVEL ORGANISM/NUCLEIC ACID WITHIN THE SAMPLE WHICH WAS NEAR/BELOW THE LIMIT OF DETECTION (LOD) FOR THE BIOFIRE ME PANEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24092407 ↗

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 Torch Module2 models · 25 reports · 1 recall
• FilmArray 2.0 Instrument2 models · 3 reports · 1 recall