FilmArray Pneumonia Panel plus (Pneumoplus)Recalls & reported problems across all models

We found 2 models of FilmArray Pneumonia Panel plus (Pneumoplus) by Biofire Diagnostics, LLC in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between May 25, 2022 and Mar 27, 2025 — classified as 3 deaths, 1 injury.

The most frequently reported specific device problem is “False Negative Result” (3 reports).

4 FDA recall records name at least one of these models by its device identifier, 4 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

FilmArray Pneumonia Panel plus (Pneumoplus) 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.

1. Aug 12, 2026Open, Classified

   Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results

   Z-0149-2027 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

2. Feb 27, 2025Class IIOpen, Classified

   Increased risk of control failures and false negative test results with multiplexed nucleic acid test.

   Z-1518-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

3. Jun 10, 2024Class IIOpen, Classified

   Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.

   Z-2683-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

4. Dec 14, 2023Class IIOpen, Classified

   Their is a potential for false positive results when using Pneumonia panel.

   Z-0993-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported FilmArray Pneumonia Panel plus (Pneumoplus) problems

FilmArray Pneumonia Panel plus (Pneumoplus) models

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

• FilmArray® Pneumonia Panel plus (Pneumoplus) RFIT-ASY-0143

  Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
  4 recalls3 deaths4 reports
• FilmArray® Pneumonia Panel plus (Pneumoplus) RFIT-ASY-0142

  Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
  1 recall0 reports

Recent FilmArray Pneumonia Panel plus (Pneumoplus) adverse event reports

The 4 most recent reports across all models, in the reporter's own words as published by the FDA.

• DeathMar 27, 2025False Negative Result; False Negative Result

  SUMMARY: (B)(6) FRANCE, REPORTED A POTENTIAL FALSE NEGATIVE KLEBSIELLA OXYTOCA, KLEBSIELLA PNEUMONIAE GROUP, AND CTX-M RESULT ON THE FILMARRAY PNEUMONIA PANEL PLUS AFTER TESTING A PATIENT'S BRONCHOALVEOLAR LAVAGE (BAL) SAMPLE. IT IS UNKNOWN IF THERE WAS ANY IMPACT TO THE PATIENT DUE TO THE FILMARRAY PNEUMONIA PANEL PLUS RESULT. BIOFIRE HAS REQUESTED FURTHER INFORMATION FROM THE CUSTOMER AND IS CURRENTLY INVESTIGATING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21715470 ↗
• DeathAug 29, 2024False Positive Result; False Positive Result

  SUMMARY: A PUBLICATION BY BAY ET AL. "PERFORMANCE AND IMPACT OF RAPID MULTIPLEX PCR ON DIAGNOSIS AND TREATMENT OF VENTILATED HOSPITAL-ACQUIRED PNEUMONIA IN PATIENTS WITH EXTENDED-SPECTRUM BETA-LACTAMASE-PRODUCING ENTEROBACTERALES RECTAL CARRIAGE" STATED THERE WERE DISCORDANT CTX-M RESULTS BETWEEN THE FILMARRAY PNEUMONIA PANEL PLUS AND CONVENTIONAL CULTURE. ACCORDING TO "SUPPLEMENTARY 2" FROM THE PUBLICATION, A PATIENT WITH A DISCORDANT CTX-M RESULT RECEIVED MEROPENEM PLUS AMIKACIN AS EMPIRICAL ANTIBIOTIC THERAPY. THE OUTCOME OF THE PATIENT WAS UNFAVORABLE, AND THEY PASSED AWAY WITHIN 48 HOURS DUE TO MULTIORGAN FAILURE. BIOFIRE REQUESTED FURTHER INFORMATION FROM THE AUTHOR TO CLARIFY WHETHER THE FILMARRAY PNEUMONIA PANEL PLUS RESULT CONTRIBUTED TO THE PATIENT'S DEATH, HOWEVER, DESPITE MULTIPLE ATTEMPTS, BIOFIRE WAS UNABLE TO RECEIVE FURTHER INFORMATION FROM THE AUTHOR. THE INVESTIGATION DETERMINED THAT THE STUDY USED A PRETREATED SAMPLE, WHICH IS AN OFF-LABEL SAMPLE TYPE, AND DEVIATED FROM THE INTENDED USE OF THE FILMARRAY PNEUMONIA PANEL PLUS. PLEASE NOTE CHECK BOX FOR "DEATH" WAS SELECTED ON SECTION B2 (OUTCOMES ATTRIBUTED TO ADVERSE EVENT) AND SECTION H1 (TYPE OF REPORTABLE EVENT

  Patient problems: Insufficient Information

  MAUDE report 20101094 ↗
• InjuryAug 23, 2024False Negative Result; False Negative Result

  SUMMARY: (B)(6) REPORTED A POTENTIAL FALSE NEGATIVE NEW DELHI METALLO-BETA-LACTAMASE (NDM) RESULT ON THE FILMARRAY PNEUMONIA PANEL PLUS AFTER TESTING A PATIENT'S SPUTUM SAMPLE. CURRENT INFORMATION FROM THE CUSTOMER INDICATES THAT THE PATIENT MAY HAVE BEEN NEGATIVELY IMPACTED BY THE BIOFIRE RESULT AND TREATMENT MAY HAVE BEEN INAPPROPRIATELY CHANGED. BIOFIRE HAS REQUESTED MORE INFORMATION TO CLARIFY PATIENT IMPACT. 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20051685 ↗
• DeathMay 25, 2022False Negative Result; False Negative Result

  SUMMARY: (B)(6) REPORTED A POTENTIAL (B)(6) RESULT ON THE BIOFIRE® FILMARRAY® PNEUMONIA PANEL PLUS AFTER TESTING A PATIENT SAMPLE. DUE TO THE BIOFIRE FILMARRAY PNEUMONIA PANEL PLUS RESULT, THE PATIENT DID NOT RECEIVE THE APPROPRIATE ANTIBIOTIC THERAPY FOR (B)(6). THE CUSTOMER REPORTED THAT THE PATIENT DIED AND THEY CANNOT EXCLUDE THAT THE DEATH IS RELATED TO THE BIOFIRE FILMARRAY PNEUMONIA PANEL PLUS RESULT. THE CUSTOMER DID NOT PROVIDE FURTHER PATIENT INFORMATION. UPON INVESTIGATION, NO MALFUNCTION OCCURRED AND THE BIOFIRE FILMARRAY PNEUMONIA PANEL PLUS WAS WORKING WITHIN SPECIFICATION. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE FOR THE DISCREPANT RESULT WAS SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN THE BIOFIRE FILMARRAY PNEUMONIA PANEL PLUS AND COMPARATOR METHODS WITH A POLYMICROBIAL CULTURE OF (B)(6).

  Patient problems: Insufficient Information

  MAUDE report 14500329 ↗

Other Biofire Diagnostics, LLC products

• FilmArray Gastrointestinal (GI) Panel2 models · 24 reports · 6 recalls
• FilmArray Pneumonia Panel (Pneumo)2 models · 7 reports · 6 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
• FilmArray Meningitis/Encephalitis (ME) Panel2 models · 32 reports