FilmArray Pneumonia Panel (Pneumo)Recalls & reported problems across all models
Biofire Diagnostics, LLC · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one FilmArray Pneumonia Panel (Pneumo) model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 5
We found 2 models of FilmArray Pneumonia Panel (Pneumo) by Biofire Diagnostics, LLC in the FDA's device registry (GUDID). Together they are named in 7 adverse event reports in the FDA's MAUDE database, 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).
5 FDA recall records name at least one of these models by its device identifier, 2 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
Reports received per month, all models
FilmArray Pneumonia Panel (Pneumo) 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.
- 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-2682-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Dec 14, 2023Open, 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 ↗
- Jun 7, 2021Terminated
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 · names 2 of these models · Recall details · FDA record ↗
- Jun 7, 2021Terminated
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 · names 2 of these models · Recall details · FDA record ↗
- Apr 16, 2021Terminated
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 FilmArray Pneumonia Panel (Pneumo) problems
Device problems
- False Positive Result7
Patient problems
- No Clinical Signs, Symptoms or Conditions7
FilmArray Pneumonia Panel (Pneumo) models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- FilmArray® Pneumonia Panel (Pneumo) RFIT-ASY-0144Respiratory Panel5 recalls7 reports
- FilmArray® Pneumonia Panel (Pneumo) RFIT-ASY-0145Respiratory Panel2 recalls0 reports
Recent FilmArray Pneumonia Panel (Pneumo) adverse event reports
The 7 most recent reports across all models, 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 ↗
Other Biofire Diagnostics, LLC products
All Biofire Diagnostics, LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page