FilmArray Gastrointestinal (GI) PanelRecalls & 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
6 open recalls name at least one FilmArray Gastrointestinal (GI) Panel model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 24
- Deaths reported
- 2
- Injuries reported
- 4
- Recalls
- 6
We found 2 models of FilmArray Gastrointestinal (GI) Panel by Biofire Diagnostics, LLC in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Jul 11, 2019 and Sep 23, 2026 — classified as 2 deaths, 4 injuries, 18 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (22 reports).
6 FDA recall records name at least one of these models by its device identifier, 6 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 Gastrointestinal (GI) Panel 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.
- May 16, 2024Open, Classified
Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.
Z-2514-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jan 26, 2024Open, Classified
Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.
Z-1140-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Nov 27, 2023Open, Classified
A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.
Z-0703-2024 · Root cause: Process control · Recall details · FDA record ↗
- Apr 25, 2023Open, Classified
The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
Z-2588-2023 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗
- Mar 8, 2023Open, Classified
Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.
Z-1392-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Feb 1, 2023Open, Classified
Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.
Z-1253-2023 · Root cause: Environmental control · Recall details · FDA record ↗
Most reported FilmArray Gastrointestinal (GI) Panel problems
Device problems
- False Positive Result22
- Incorrect, Inadequate or Imprecise Result or Readings2
- False Negative Result1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Insufficient Information10
- No Known Impact Or Consequence To Patient2
- Colitis1
- Death1
- Sepsis1
FilmArray Gastrointestinal (GI) Panel models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- FilmArray® Gastrointestinal (GI) Panel RFIT-ASY-0116Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System6 recalls2 deaths24 reports
- FilmArray® Gastrointestinal (GI) Panel RFIT-ASY-0104Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System1 recall0 reports
Recent FilmArray Gastrointestinal (GI) Panel adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 23, 2026False Positive Result
Summary: The customer "[(b)(6) Canada]" reported a potential false positive Yersinia enterocolitica result on the FilmArray Gastrointestinal (GI) Panel after testing a patient's stool sample. The customer reported that due to the GI Panel result, the patient was indirectly impacted, specifically unnecessary treatment, which might lead to serious injury if it were to recur. No patient harm was reported. Based on the information provided, the investigation concluded that the most likely cause for the discrepant result was low-level organism/nucleic acid contamination.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50866621 ↗InjurySep 10, 2026False Positive Result
Summary: The customer (Aviles, Spain) reported a potential false positive Giardia lamblia (G. lamblia) result on the BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel after testing a patient stool sample. The customer reported that due to the GI Panel result, the patient was indirectly impacted, specifically by inappropriate 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 50714064 ↗DeathSep 17, 2025False Positive Result; False Positive Result
SUMMARY: (B)(6) HOSPITAL (B)(6) REPORTED A POTENTIAL FALSE POSITIVE ENTEROTOXIGENIC ESCHERICHIA COLI (ETEC) LT/ST, SHIGA-LIKE TOXIN-PRODUCING ESCHERICHIA COLI (STEC) STX1/STX2, AND E. COLI O157 RESULTS ON THE FILMARRAY GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE IN CARY BLAIR TRANSPORT MEDIA. THE CUSTOMER REPORTED ANTIBIOTIC THERAPY WAS NOT GIVEN DUE TO THE POSITIVE E. COLI O157 RESULT AND THE PATIENT PASSED AWAY. 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; Sepsis
MAUDE report 23078175 ↗MalfunctionJun 28, 2024False Positive Result; False Positive Result
SUMMARY: (B)(6) HOSPITAL ((B)(6)) REPORTED TWO POTENTIAL FALSE POSITIVE VIBRIO AND VIBRIO CHOLERA RESULTS ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE. THE PATIENT WAS NOT IMPACTED DUE TO THE BIOFIRE GI PANEL RESULTS AS IT WAS NOT REPORTED TO THE PHYSICIAN. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT RESULTS WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19635411 ↗MalfunctionJun 18, 2024False Positive Result; False Positive Result
SUMMARY: (B)(6) REPORTED A POTENTIAL FALSE POSITIVE VIBRIO RESULT ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE. DUE TO THE BIOFIRE GI PANEL RESULT, IT IS UNKNOWN IF THE PATIENT WAS IMPACTED. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT VIBRIO RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.
Patient problems: Insufficient Information
MAUDE report 19563844 ↗MalfunctionJun 11, 2024False Positive Result; False Positive Result
SUMMARY: (B)(6) HOSPITAL (B)(6)) REPORTED A POTENTIAL FALSE POSITIVE VIBRIO CHOLERA RESULT ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE. DUE TO THE BIOFIRE GI PANEL RESULT, IT IS UNKNOWN IF THE PATIENT WAS IMPACTED. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT V. CHOLERA RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19510011 ↗MalfunctionJun 5, 2024False Positive Result; False Positive Result
SUMMARY: (B)(6) HOSPITAL ((B)(6)) REPORTED A POTENTIAL FALSE POSITIVE VIBRIO RESULT ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE. THE CUSTOMER STATED THAT THE PATIENT WAS POSSIBLY PLACED INTO CONTACT PRECAUTIONS DUE TO THE DISCREPANCY. NO SERIOUS INJURY OR DEATH WAS REPORTED. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT VIBRIO RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.
Patient problems: Insufficient Information
MAUDE report 19472701 ↗MalfunctionApr 29, 2024False Positive Result; False Positive Result
SUMMARY: CLÍNICA INDISA (PROVIDENCIA, CHILE) REPORTED A POTENTIAL FALSE POSITIVE VIBRIO RESULT ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE. THE PATIENT IMPACT DUE TO THE BIOFIRE GI PANEL IS UNKNOWN. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT VIBRIO RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.
Patient problems: Insufficient Information
MAUDE report 19205605 ↗MalfunctionApr 3, 2024False Positive Result; False Positive Result
SUMMARY: LANCET LAB (BLOEMFONTEIN, SOUTH AFRICA) REPORTED A POTENTIAL FALSE POSITIVE VIBRIO CHOLERAE RESULT ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE. DUE TO THE BIOFIRE GI PANEL RESULT, THE PATIENT MAY HAVE RECEIVED INAPPROPRIATE TREATMENT AND ALSO HAD TO BE ISOLATED. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT V. CHOLERAE RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.
Patient problems: Insufficient Information
MAUDE report 19037445 ↗MalfunctionApr 3, 2024False Positive Result; False Positive Result
SUMMARY: LANCET LAB (BLOEMFONTEIN, SOUTH AFRICA) REPORTED A POTENTIAL FALSE POSITIVE VIBRIO CHOLERAE RESULT ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE. DUE TO THE BIOFIRE GI PANEL RESULT, THE PATIENT RECEIVED INAPPROPRIATE TREATMENT AND HAD TO BE ISOLATED. NO SERIOUS INJURY OR DEATH WAS REPORTED. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT V. CHOLERAE RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.
Patient problems: Insufficient Information
MAUDE report 19037422 ↗MalfunctionMar 28, 2024False Positive Result; False Positive Result
SUMMARY: (B)(6) HOSPITAL ((B)(6)) REPORTED A POTENTIAL FALSE POSITIVE VIBRIO RESULT ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE IN CARY BLAIR TRANSPORT MEDIA. THE PATIENT WAS NOT AFFECTED DUE TO THE BIOFIRE GI PANEL RESULT AS THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT VIBRIO RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19001118 ↗MalfunctionMar 28, 2024False Positive Result; False Positive Result
SUMMARY: (B)(6) HOSPITAL REPORTED A POTENTIAL FALSE POSITIVE VIBRIO CHOLERAE RESULT ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE IN CARY BLAIR TRANSPORT MEDIA. THE PATIENT WAS NOT AFFECTED DUE TO THE BIOFIRE GI PANEL RESULT AS THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT V. CHOLERAE RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19001004 ↗MalfunctionMar 28, 2024False Positive Result; False Positive Result
SUMMARY: (B)(6) MEDICAL CENTER ((B)(6)) REPORTED A POTENTIAL FALSE POSITIVE VIBRIO RESULT ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE IN CARY BLAIR TRANSPORT MEDIA. IT IS UNKNOWN IF THE PATIENT WAS IMPACTED DUE TO THE BIOFIRE GI PANEL RESULT. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT VIBRIO RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.
Patient problems: Insufficient Information
MAUDE report 19000844 ↗MalfunctionMar 28, 2024False Positive Result; False Positive Result
SUMMARY: HAMPTON VA MEDICAL CENTER (HAMPTON, VA) REPORTED A POTENTIAL FALSE POSITIVE VIBRIO RESULT ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE IN CARY BLAIR TRANSPORT MEDIA. IT IS UNKNOWN IF THE PATIENT WAS IMPACTED DUE TO THE BIOFIRE GI PANEL RESULT. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT VIBRIO RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.
Patient problems: Insufficient Information
MAUDE report 19000623 ↗MalfunctionMar 28, 2024False Positive Result; False Positive Result
SUMMARY: (B)(6) HOSPITAL REPORTED A POTENTIAL FALSE POSITIVE VIBRIO RESULT ON THE BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE IN CARY BLAIR TRANSPORT MEDIA. THE CUSTOMER STATED THAT THE PATIENT WAS NOT AFFECTED DUE TO THE BIOFIRE GI PANEL RESULT. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT VIBRIO RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE CARY BLAIR TRANSPORT MEDIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19000527 ↗
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.
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