FilmArray® Pneumonia Panel plus (Pneumoplus) RFIT-ASY-0143Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815381020314), 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).

3 FDA recall records name this device's identifier, 3 still open.

1 other recall cover devices cleared under the same FDA submission (K181324, K222601, K243222); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 27, 2025Open, Classified

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

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

2. Jun 10, 2024Open, 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 · FDA record ↗

3. Dec 14, 2023Open, Classified

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

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

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181324, K222601, K243222. One submission often covers many models, so check the product and lot details in each record.

• Z-2040-2021 · Jun 7, 2021 · Terminated
  FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit) Part No: RFIT-ASY-0142 / UDI: 00815381020321 (6 test kit)