FilmArray® Torch Module HTFA-SUB-0103Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00815381020277), received between Oct 10, 2024 and Sep 10, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (15 reports).

1 FDA recall record name this device's identifier, 1 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, 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 16, 2026.

Recalls naming this device

1. Aug 7, 2024Class IIOpen, Classified

   Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting temperatures, which may lead to erroneous results including false positive Salmonella, Giardia lamblia, false positive/negative Norovirus, and false negative MRSA.

   Z-3123-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50714690 ↗
• MalfunctionSep 10, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50714671 ↗
• MalfunctionAug 26, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50450088 ↗
• MalfunctionAug 26, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50449986 ↗
• MalfunctionAug 26, 2026False Positive Result

  (b)(6) Hospital ((b)(6) MD) reported potential false positive Coronavirus HKU1 and Parainfluenza virus 4 results on FilmArray® Torch Module (b)(6) after testing the patient¿s nasopharyngeal (NP) sample with the BioFire® Respiratory Panel 2.1 Panel. No patient harm was reported. A potential product malfunction was identified. Torch Module (b)(6) was returned for the investigation. 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 50449976 ↗
• MalfunctionAug 26, 2026False Positive Result

  (b)(6) reported a potential false positive Parainfluenza virus 4 result on FilmArray® Torch Module TM25540 after testing the patient¿s bronchoalveolar lavage (BAL) sample with the BioFire® Respiratory Panel 2.1 Panel. No patient harm was reported. A potential product malfunction was identified. Torch Module TM25540 was returned for the investigation. 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 50449971 ↗
• MalfunctionAug 26, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50449969 ↗
• MalfunctionAug 26, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50449890 ↗
• MalfunctionAug 26, 2026False Positive Result

  (b)(6) reported potential false positive Human metapneumovirus, Influenza A H1, and Parainfluenza virus 4 results on FilmArray® Torch Module (b)(6) after testing the patient¿s nasopharyngeal (NP) sample with the BioFire® Respiratory Panel 2.1 Panel. No patient harm was reported. A potential product malfunction was identified. Torch Module (b)(6) was returned for the investigation. 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 50449879 ↗
• MalfunctionApr 30, 2026False Positive Result

  (B)(6) ((B)(6), FRANCE) REPORTED A POTENTIAL FALSE-POSITIVE NEISSERIA MENINGITIDIS RESULT ON THE FILMARRAY® MENINGITIS/ENCEPHALITIS (ME) PANEL AFTER TESTING A PATIENT CSF SAMPLE. THE CUSTOMER REPORTED THAT DUE TO THE ME PANEL THE PATIENT WAS AFFECTED DUE TO PROLONGED TREATMENT (INAPPROPRIATE TREATMENT). NO PATIENT HARM WAS REPORTED. A POTENTIAL PRODUCT MALFUNCTION WAS IDENTIFIED. THE INVESTIGATION FOUND THAT THE MOST LIKELY CAUSE OF THE DISCREPANT RESULT WAS A POSSIBLE INSTRUMENT ERROR OR POUCH ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25044907 ↗
• MalfunctionSep 24, 2025False Negative Result; False Negative Result

  SUMMARY: (B)(6) REPORTED A POTENTIAL FALSE NEGATIVE RESULTS ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL RUNS ON THE FILMARRAY TORCH MODULE (B)(6). NO PATIENT HARM WAS REPORTED. THE INVESTIGATION DETERMINED THAT THE MOST PROBABLE CAUSE OF THE DISCREPANT RESULT WAS A PATIENT LABEL BECOMING DISLODGED WITHIN THE FILMARRAY TORCH MODULE, OBSTRUCTING THE CAMERA.

  Patient problems: Insufficient Information

  MAUDE report 23137225 ↗
• MalfunctionSep 19, 2025False Negative Result; False Negative Result

  SUMMARY: MISSION REGIONAL MEDICAL CENTER (MISSION, TX) REPORTED POTENTIAL FALSE NEGATIVE STAPHYLOCOCCUS AUREUS RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL RUN ON THE FILMARRAY TORCH MODULE (B)(6). THE PATIENT'S RESULT WAS DELAYED DUE TO THE DISCREPANT RESULT. A MALFUNCTION OF THE FILMARRAY TORCH INSTRUMENT (B)(6) IS SUSPECTED. A FINAL REPORT WITH ALL INVESTIGATION DETAILS WILL BE PROVIDED. 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 23103295 ↗
• MalfunctionSep 19, 2025False Negative Result; False Negative Result

  SUMMARY: (B)(6) REPORTED A POTENTIAL FALSE NEGATIVE STAPHYLOCOCCUS AUREUS RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL RUN ON THE FILMARRAY TORCH MODULE (B)(6). THE PATIENT WAS NOT IMPACTED DUE TO THE DISCREPANT RESULT. BASED ON THE INFORMATION PROVIDED, AND INTERNAL TESTING ON THE INSTRUMENT, THE INVESTIGATION CONCLUDED THE MOST LIKELY CAUSE FOR THE REPORTED DISCREPANCY WAS DUE TO A FILMARRAY TORCH MODULE ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23103294 ↗
• MalfunctionSep 19, 2025False Negative Result; False Negative Result

  SUMMARY: (B)(6) REPORTED POTENTIAL FALSE NEGATIVE METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL. THE PATIENT'S APPROPRIATE TREATMENT WAS DELAYED DUE TO THE DISCREPANT RESULT. THE INVESTIGATION CONCLUDED THAT THE MOST PROBABLE CAUSE OF THE DISCREPANT MRSA RESULTS ON THE BIOFIRE BCID2 PANEL WAS THE PRESENCE OF AN MREJ STRAIN EXHIBITING REDUCED REACTIVITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23103293 ↗
• MalfunctionSep 17, 2025False Negative Result; False Negative Result

  SUMMARY: (B)(6) HOSPITAL (B)(6) JAPAN) REPORTED A POTENTIAL FALSE NEGATIVE ACINETOBACTER CALCOACETICUS-BAUMANNII (ACB) COMPLEX RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL RUN ON THE FILMARRAY TORCH MODULE AFTER TESTING A PATIENT'S BLOOD CULTURE SAMPLE. IT IS UNKNOWN IF THERE WAS IMPACT TO THE PATIENT DUE TO THE BIOFIRE BCID2 PANEL RESULT. THE INVESTIGATION CONCLUDED THAT THE CAUSE OF THE DISCREPANCY WAS FILMARRAY TORCH MODULE (B)(6) ISSUE DUE TO A DELAMINATED WINDOW BLADDER THAT AFFECTED INSTRUMENT PERFORMANCE.

  Patient problems: Insufficient Information

  MAUDE report 23079571 ↗
• MalfunctionAug 22, 2025False Negative Result; False Negative Result

  SUMMARY: (B)(6) HOSPITAL ((B)(6)) REPORTED POTENTIAL FALSE NEGATIVE RESULTS ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL RUNS ON THE FILMARRAY TORCH MODULE (B)(6). NO PATIENT HARM WAS REPORTED. A MALFUNCTION OF THE FILMARRAY TORCH INSTRUMENT (B)(6) IS SUSPECTED. A FINAL REPORT WITH ALL INVESTIGATION DETAILS WILL BE PROVIDED. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FIELD SAFETY CORRECTIVE ACTION (FSCA) HAS BEEN DEEMED NECESSARY AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 22879216 ↗
• MalfunctionAug 22, 2025False Negative Result; False Negative Result

  SUMMARY: (B)(6) HOSPITAL ((B)(6)) REPORTED A POTENTIAL FALSE NEGATIVE RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL RUN ON THE FILMARRAY TORCH MODULE (B)(6). NO PATIENT HARM WAS REPORTED. A MALFUNCTION OF THE FILMARRAY TORCH INSTRUMENT (B)(6) IS SUSPECTED. A FINAL REPORT WITH ALL INVESTIGATION DETAILS WILL BE PROVIDED. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FIELD SAFETY CORRECTIVE ACTION (FSCA) HAS BEEN DEEMED NECESSARY AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 22879215 ↗
• MalfunctionAug 22, 2025False Negative Result; False Negative Result

  SUMMARY: (B)(6) HOSPITAL (B)(6) REPORTED POTENTIAL FALSE NEGATIVE RESULTS ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL RUN ON THE FILMARRAY TORCH MODULE (B)(6). NO PATIENT HARM WAS REPORTED. A MALFUNCTION OF THE FILMARRAY TORCH INSTRUMENT (B)(6) IS SUSPECTED. A FINAL REPORT WITH ALL INVESTIGATION DETAILS WILL BE PROVIDED. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FIELD SAFETY CORRECTIVE ACTION (FSCA) HAS BEEN DEEMED NECESSARY AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 22879214 ↗
• MalfunctionAug 22, 2025False Negative Result; False Negative Result

  SUMMARY: (B)(6) HOSPITAL ((B)(6)) REPORTED POTENTIAL FALSE NEGATIVE RESULTS ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL RUNS ON THE FILMARRAY TORCH MODULE (B)(6). NO PATIENT HARM WAS REPORTED. A MALFUNCTION OF THE FILMARRAY TORCH INSTRUMENT (B)(6) IS SUSPECTED. A FINAL REPORT WITH ALL INVESTIGATION DETAILS WILL BE PROVIDED. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FIELD SAFETY CORRECTIVE ACTION (FSCA) HAS BEEN DEEMED NECESSARY AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 22879213 ↗
• MalfunctionMay 29, 2025False Negative Result; False Negative Result

  SUMMARY: (B)(6) HOSPITAL (B)(6), IN) REPORTED A POTENTIAL FALSE NEGATIVE PSEUDOMONAS AERUGINOSA RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL RUN ON THE FILMARRAY TORCH SYSTEM AFTER TESTING A PATIENT'S BLOOD CULTURE SAMPLE. DUE TO THE BIOFIRE BCID2 PANEL RESULT, THE PATIENT'S RESULTS WERE DELAYED. NO PATIENT HARM WAS REPORTED. THE INVESTIGATION CONCLUDED THE MOST LIKELY CAUSE FOR THE DISCREPANCY WAS A FILMARRAY TORCH INSTRUMENT (B)(6) ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22109068 ↗
• MalfunctionNov 15, 2024False Negative Result; False Negative Result

  SUMMARY: GULF INTEGRATED SECURITY SOLUTIONS (KUWAIT FREE TRADE ZONE, KUWAIT) REPORTED A POTENTIAL FALSE NEGATIVE STENOTROPHOMONAS MALTOPHILIA RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A PATIENT'S BLOOD CULTURE SAMPLE. DUE TO THE BIOFIRE BCID2 PANEL RESULTS, THE PATIENT HAD EXTENDED HOSPITAL STAY AND A DELAY IN ANTIBIOTIC TREATMENT. NO SERIOUS INJURY OR DEATH WAS REPORTED. THE INVESTIGATION CONCLUDED THE MOST LIKELY CAUSE FOR THE DISCREPANCY WAS A FILMARRAY TORCH INSTRUMENT (TM03161) ERROR.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20698819 ↗
• MalfunctionNov 15, 2024False Negative Result; False Negative Result

  SUMMARY: (B)(6) (KUWAIT FREE TRADE ZONE, KUWAIT) REPORTED A POTENTIAL FALSE NEGATIVE STENOTROPHOMONAS MALTOPHILIA RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A PATIENT'S BLOOD CULTURE SAMPLE. NO SERIOUS INJURY OR DEATH WAS REPORTED. DUE TO THE BIOFIRE BCID2 PANEL RESULT, THE PATIENT HAD EXTENDED HOSPITAL STAY AND A DELAY IN ANTIBIOTIC TREATMENT. THE INVESTIGATION CONCLUDED THE MOST LIKELY CAUSE FOR THE DISCREPANCY WAS FILMARRAY TORCH INSTRUMENT (B)(6) ERROR.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20698696 ↗
• MalfunctionOct 10, 2024False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event

  SUMMARY: (B)(6) ((B)(6) INDIA) REPORTED A POTENTIAL FALSE NEGATIVE ESCHERICHIA COLI RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A PATIENT'S SAMPLE. IT IS UNKNOWN IF THE PATIENT WAS IMPACTED DUE TO THE BIOFIRE BCID2 RESULT. A MALFUNCTION OF THE FILMARRAY TORCH INSTRUMENT (B)(6) WAS SUSPECTED AND INVESTIGATED. AFTER INVESTIGATION, IT WAS FOUND THAT THIS DOES NOT MEET CRITERIA FOR A REPORTABLE EVENT. THERE WAS NO OCCURRENCE OF A MALFUNCTION THAT WOULD CAUSE OR CONTRIBUTE SERIOUS INJURY OR DEATH IF IT WERE TO RECUR. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FIELD SAFETY CORRECTIVE ACTION (FSCA) HAS BEEN DEEMED NECESSARY AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20424577 ↗
• MalfunctionOct 10, 2024False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event

  SUMMARY: (B)(6) HOSPITALS PRIVATE LIMITED (B)(6) INDIA) REPORTED A POTENTIAL FALSE NEGATIVE ESCHERICHIA COLI RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A PATIENT'S SAMPLE. IT IS UNKNOWN IF THE PATIENT WAS IMPACTED DUE TO THE BIOFIRE BCID2 RESULT. A MALFUNCTION OF THE FILMARRAY TORCH INSTRUMENT (TM16159) WAS SUSPECTED AND INVESTIGATED. AFTER INVESTIGATION, IT WAS FOUND THAT THIS DOES NOT MEET CRITERIA FOR A REPORTABLE EVENT. THERE WAS NO OCCURRENCE OF A MALFUNCTION THAT WOULD CAUSE OR CONTRIBUTE SERIOUS INJURY OR DEATH IF IT WERE TO RECUR. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FIELD SAFETY CORRECTIVE ACTION (FSCA) HAS BEEN DEEMED NECESSARY AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20424103 ↗
• MalfunctionOct 10, 2024False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event

  SUMMARY: (B)(6) HOSPITALS PRIVATE LIMITED (B)(6) REPORTED A POTENTIAL FALSE NEGATIVE ESCHERICHIA COLI RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A PATIENT'S SAMPLE. IT IS UNKNOWN IF THE PATIENT WAS IMPACTED DUE TO THE BIOFIRE BCID2 RESULT. A MALFUNCTION OF THE FILMARRAY TORCH INSTRUMENT (B)(6) WAS SUSPECTED AND INVESTIGATED. AFTER INVESTIGATION, IT WAS FOUND THAT THIS DOES NOT MEET CRITERIA FOR A REPORTABLE EVENT. THERE WAS NO OCCURRENCE OF A MALFUNCTION THAT WOULD CAUSE OR CONTRIBUTE SERIOUS INJURY OR DEATH IF IT WERE TO RECUR. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FIELD SAFETY CORRECTIVE ACTION (FSCA) HAS BEEN DEEMED NECESSARY AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20424068 ↗