FilmArray® Torch System Base HTFA-ASY-0104Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815381020253), received between Jun 14, 2025 and Sep 23, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K160068); 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. Oct 17, 2023Class IIOpen, Classified

   Due to an increased risk of degradation of the power entry switch resulting from arcing inside of the power switch that may result in carbon build-up on the switch contacts. The carbon build-up may lead to excess heating inside of the power switch, subsequently leading to deformation of the power switch case. The deformation can create an opportunity for a power switch electrical short. In addition to an electrical short, deformation may result in an open circuit causing the power switch to fail. This event would only occur after the product is in use.

   Z-0353-2024 · Root cause: Device Design · Recall details · 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.

• MalfunctionSep 23, 2026Failure to Power Up

  (b)(6) Hospital reported a burned/melted power cord on BIOFIRE® FILMARRAY® TORCH base (b)(6). The customer discovered the burned power cable while installing the fused extension cable on their TORCH base. The images provided by the customer confirm the reported issue of a burned power cord. No operator harm was reported. A potential product malfunction was identified. TORCH base (b)(6) has been requested to be 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 50871747 ↗
• MalfunctionAug 24, 2026Failure to Power Up

  Summary:(b)(6) reported a burnt power entry module on BIOFIRE® FILMARRAY® TORCH base (b)(6). During troubleshooting, a burnt power entry module and cable were noticed. The images provided by the customer confirm reported issue of burnt prongs on the TORCH base. The customer confirmed no harm or injury to the operator. A potential product malfunction was identified. TORCH base (b)(6) has been requested to be returned for the investigation and attempts for the instrument's return are still ongoing. Update for follow up report:BioFire is still investigating this event in order to determine the root cause. The full investigation and associated conclusions will be provided in the final supplemental report. No remedial action, corrective action, preventive action, or FSCA has been deemed necessary at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50408512 ↗
• MalfunctionOct 29, 2025Overheating of Device; Overheating of Device

  SUMMARY: ((B)(6) BRAZIL) REPORTED A BURNING SMELL COMING FROM THE FILMARRAY TORCH SYSTEM BASE OVER A PERIOD OF SEVERAL DAYS. THE IMAGES PROVIDED BY THE CUSTOMER SHOW THAT THE POWER CORD APPEARS TO HAVE BURNED/MELTED AT THE POINT OF CONTACT WITH THE FILMARRAY TORCH SYSTEM BASE. THE CUSTOMER REPORTED THAT THERE WAS NO IMPACT ON USERS OR PATIENTS. BIOFIRE IS CURRENTLY INVESTIGATING THIS EVENT. THE FULL INVESTIGATION AND ASSOCIATED CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23415490 ↗
• MalfunctionJun 14, 2025Fire; Fire

  SUMMARY: (B)(6) REPORTED THAT A FILMARRAY TORCH SYSTEM BASE CAUGHT ON FIRE. THE CUSTOMER REPORTED THAT THERE WAS NO IMPACT TO TEAM MEMBERS, PATIENT OR PATIENT CARE. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE OF THE FIRE WAS DUE TO A FAILURE OF THE POWER SWITCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22208532 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160068. One submission often covers many models, so check the product and lot details in each record.

• Z-3123-2024 · Aug 7, 2024 · Open, Classified
  FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U