FilmArray® Pneumonia Panel (Pneumo) RFIT-ASY-0144Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00815381020178), received between May 14, 2026 and Aug 16, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (7 reports).

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

3 other recalls cover devices cleared under the same FDA submission (K180966, K212727, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

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-0148-2027 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. 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-2682-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

3. Dec 14, 2023Class IIOpen, Classified

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

   Z-0994-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Jun 7, 2021Class IITerminated

   Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.

   Z-2039-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. Jun 7, 2021Class IITerminated

   Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.

   Z-2040-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. Apr 16, 2021Class IITerminated

   Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.

   Z-1944-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50267950 ↗
• MalfunctionAug 16, 2026False Positive Result

  The customer "[California, USA]" reported a potential false positive Coronavirus result on the BioFire FilmArray® Pneumonia Panel after testing a patient sample. The patient was not impacted by the result. A potential product malfunction was identified. BioFire has requested further information from the customer and is currently investigating this event. Similar events have been observed in the field with BioFire FilmArray® Pneumonia Panel and Pneumonia Plus Panels. A field safety corrective action (FSCA) was issued in the U.S. in February 2025 via FSCA 5790 to update the panel software. At the time this complaint was received, the customer had not implemented the updated software.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50267655 ↗
• MalfunctionAug 16, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50267350 ↗
• MalfunctionAug 16, 2026False Positive Result

  The customer (b)(6) reported a potential false positive Coronavirus result on the BioFire FilmArray® Pneumonia Panel after testing a patient sample. The patient was not impacted by the result. A potential product malfunction was identified. BioFire has requested further information from the customer and is currently investigating this event. Similar events have been observed in the field with BioFire FilmArray® Pneumonia Panel and Pneumonia Plus Panels. A field safety corrective action (FSCA) was issued in the U.S. in February 2025 via FSCA 5790 to update the panel software. At the time this complaint was received, the customer had not implemented the updated software.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50267267 ↗
• MalfunctionAug 16, 2026False Positive Result

  The customer "[California, USA]" reported a potential false positive Coronavirus result on the BioFire FilmArray® Pneumonia Panel after testing a patient sample. The patient was not impacted by the result. A potential product malfunction was identified. BioFire has requested further information from the customer and is currently investigating this event. Similar events have been observed in the field with BioFire FilmArray® Pneumonia Panel and Pneumonia Plus Panels. A field safety corrective action (FSCA) was issued in the U.S. in February 2025 via FSCA 5790 to update the panel software. At the time this complaint was received, the customer had not implemented the updated software.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50264482 ↗
• MalfunctionAug 16, 2026False Positive Result

  The customer "[California, USA]" reported a potential false positive Coronavirus result on the BioFire FilmArray® Pneumonia Panel after testing a patient sample. The patient was not impacted by the result. A potential product malfunction was identified. BioFire has requested further information from the customer and is currently investigating this event. Similar events have been observed in the field with BioFire FilmArray® Pneumonia Panel and Pneumonia Plus Panels. A field safety corrective action (FSCA) was issued in the U.S. in February 2025 via FSCA 5790 to update the panel software. At the time this complaint was received, the customer had not implemented the updated software.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50263568 ↗
• MalfunctionMay 14, 2026False Positive Result

  (B)(6) REPORTED A POTENTIAL FALSE POSITIVE CTX-M RESULT ON THE BIOFIRE FILMARRAY PNEUMONIA PANEL (PN PANEL) AFTER TESTING A PATIENT'S SPUTUM SAMPLE. THE CUSTOMER REPORTED THAT DUE TO THE PN PANEL RESULT, THE PATIENT POTENTIALLY RECEIVED INAPPROPRIATE TREATMENT MODIFICATION; HOWEVER, NO SUBSEQUENT PATIENT HARM WAS REPORTED. A POTENTIAL PRODUCT MALFUNCTION WAS IDENTIFIED. BIOFIRE IS CURRENTLY INVESTIGATING THIS EVENT. PRELIMINARY INVESTIGATION INDICATES A MALFUNCTION ASSOCIATED WITH A HIGH TM CTX-M SIGNATURE, SIMILARLY OBSERVED WITH THE CTX-M ASSAY HGDNA CROSS-REACTIVITY. A PREVENTIVE ACTION WAS IMPLEMENTED IN THE FSCA 5790 UPDATE SOFTWARE RELEASE TO MITIGATE THE POTENTIAL FOR OCCURRENCE OF CTX-M FALSE POSITIVE RESULTS ASSOCIATED WITH HUMAN GENOMIC DNA (HGDNA) CROSS-REACTIVITY IN THE FIELD. THIS SOFTWARE UPDATE WAS RELEASED IN (B)(6) 2025. AT THE TIME THIS COMPLAINT WAS RECEIVED, THE CUSTOMER HAD NOT IMPLEMENTED THE UPDATED SOFTWARE. THE CUSTOMER HAS SINCE BEEN ADVISED TO PERFORM THE SOFTWARE UPDATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25175369 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K180966, K212727, K243222. One submission often covers many models, so check the product and lot details in each record.

• Z-0149-2027 · Aug 12, 2026 · Open, Classified
  Generic Name: FilmArray Pneumonia Panel plus Generic Name: FilmArray Pneumonia Panel plus Model/Catalog Number: RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit) Software Version: N/A
• Z-1518-2025 · Feb 27, 2025 · Open, Classified
  FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
• Z-2440-2023 · May 8, 2023 · Open, Classified
  FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only