FilmArray® Torch Module HTFA-ASY-0003-WRecalls & reported problems
Biofire Diagnostics, LLC · Refurbished IVD Instrument (FilmArray® Torch Module) · Class 2
All models of FilmArray Torch Module (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
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 18, 2026.
Recalls naming this device
- 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 ↗
Other Instrumentation For Clinical Multiplex Test Systems devices
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- Verigene® Processor SP (Refurbished) 10-0000-07RLuminex Corporation · Instrumentation for clinical multiplex test systems3 recalls6 reports
- BD MAX™ Vaginal Panel 443712Becton, Dickinson And Company · Instrumentation For Clinical Multiplex Test Systems1 recall50 reports
- DASH® Rapid PCR Instrument DASH-0002Nuclein, LLC · Instrumentation For Clinical Multiplex Test Systems2 recalls0 reports
- FilmArray® Torch Module HTFA-SUB-0103Biofire Diagnostics, LLC · Instrumentation For Clinical Multiplex Test Systems1 recall25 reports
- FilmArray® Torch System Base HTFA-ASY-0104Biofire Diagnostics, LLC · Instrumentation For Clinical Multiplex Test Systems1 recall4 reports
- FilmArray® 2.0 Instrument FLM2-ASY-0001Biofire Diagnostics, LLC · Instrumentation For Clinical Multiplex Test Systems1 recall3 reports
- FilmArray® 2.0 Instrument FLM2-ASY-0001-WBiofire Diagnostics, LLC · Instrumentation For Clinical Multiplex Test Systems1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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