Z-0353-2024.jsonld
type: Dataset
name: FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB ports. The BioFire FilmArray Torch (BioFire Torch) is an automated in vitro diagnostic (IVD) device intended for use with FDA-cleared or approved IVD BioFire FilmArray Panels. Additional Part/Reference Numbers as part of the system: - HTFA-ASY-0102: BIOFIRE TORCH Duplex. This is a plastic component that covers the BIOFIRE TORCH Modules. The BIOFIRE TORCH Duplex is only necessary if the system includes more than two modules. - HFTA-SUB-0103: BIOFIRE TORCH Module. The BIOFIRE reagent pouches are inserted into the modules.
description: FDA recall Z-0353-2024 — BioFire Diagnostics, LLC is recalling FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB ports. The BioFire FilmArray Torch (BioFire Torch) is an automated in vitro diagnostic (IVD) device intended for use with FDA-cleared or approved IVD BioFire FilmArray Panels. Additional Part/Reference Numbers as part of the system: - HTFA-ASY-0102: BIOFIRE TORCH Duplex. This is a plastic component that covers the BIOFIRE TORCH Modules. The BIOFIRE TORCH Duplex is only necessary if the system includes more than two modules. - HFTA-SUB-0103: BIOFIRE TORCH Module. The BIOFIRE reagent pouches are inserted into the modules. (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.
license: https://creativecommons.org/publicdomain/zero/1.0/
is accessible for free: true
is part of: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
is defined by: https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native
see also: https://agenticu.ryanjhunter.workers.dev/commons/the-research-object
date modified: 2026-06-24T07:02:03.626072+00:00
is based on: openFDA drug & device enforcement (recall) reports
  type: Dataset
  creator: U.S. Food & Drug Administration
about: MedicalDevice
  name: FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB ports. The BioFire FilmArray Torch (BioFire Torch) is an automated in vitro diagnostic (IVD) device intended for use with FDA-cleared or approved IVD BioFire FilmArray Panels. Additional Part/Reference Numbers as part of the system: - HTFA-ASY-0102: BIOFIRE TORCH Duplex. This is a plastic component that covers the BIOFIRE TORCH Modules. The BIOFIRE TORCH Duplex is only necessary if the system includes more than two modules. - HFTA-SUB-0103: BIOFIRE TORCH Module. The BIOFIRE reagent pouches are inserted into the modules.
  manufacturer: BioFire Diagnostics, LLC
claims: enforcement-record
claims: FDA classified recall Z-0353-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0353-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0353-2024
      status: recorded
  item list element: ListItem
    position: 2
    item:
      field: Product type
      value: Devices
      status: recorded
  item list element: ListItem
    position: 3
    item:
      field: Classification
      value: Class II
      status: determination
  item list element: ListItem
    position: 4
    item:
      field: Status
      value: Ongoing — the recall is still being carried out.
      status: recorded
  item list element: ListItem
    position: 5
    item:
      field: Recalling firm
      value: BioFire Diagnostics, LLC
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: 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.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2023-10-17
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: Model/Part Number: HTFA-ASY-0104 UDI-DI Code: 00815381020253 Serial Numbers: All serial numbers (listed below) U.S. KTB00006 KTB00007 KTB00008 KTB00009 KTB00011 KTB00012 KTB00014 KTB00015 KTB00016 KTB00017 KTB00018 KTB00019 KTB00020 KTB00021 KTB00022 KTB00023 KTB00025 KTB00026 KTB00027 KTB00029 KTB00030 KTB00031 KTB00032 KTB00033 KTB00034 KTB00035 KTB00036 KTB00037 KTB00038 KTB00039 KTB00040 KTB00041 KTB00044 KTB00045 KTB00046 KTB00053 KTB00056 KTB00058 KTB00059 KTB00060 KTB00061 KTB00062 KTB00063 KTB00064 KTB00065 KTB00066 KTB00068 KTB00069 KTB00070 KTB00071 KTB00072 KTB00073 KTB00074 KTB00075 KTB00076 KTB00077 KTB00078 KTB00079 KTB00082 KTB00083 KTB00084 KTB00085 KTB00086 KTB00087 KTB00088 KTB00089 KTB00090 KTB00091 KTB00092 KTB00093 KTB00094 KTB00095 KTB00101 KTB00105 KTB00107 KTB00108 KTB00110 KTB00119 KTB00120 KTB00121 KTB00122 KTB00123 KTB00124 KTB00125 KTB00126 KTB00128 KTB00129 KTB00130 KTB00131 KTB00132 KTB00133 KTB00134 KTB00135 KTB00136 KTB00137 KTB00139 KTB00140 KTB00142 KTB00143 KTB00144 KTB00145 KTB00146 KTB00147 KTB00148 KTB00149 KTB00150 KTB00151 KTB00152 KTB00154 KTB00155 KTB00159 KTB00160 KTB00161 KTB00163 KTB00165 KTB00173 KTB00174 KTB00175 KTB00177 KTB00178 KTB00179 KTB00182 KTB00183 KTB00184 KTB00185 KTB00186 KTB00187 KTB00188 KTB00189 KTB00190 KTB00191 KTB00193 KTB00194 KTB00195 KTB00196 KTB00197 KTB00199 KTB00200 KTB00201 KTB00202 KTB00203 KTB00205 KTB00206 KTB00209 KTB00211 KTB00212 KTB00213 KTB00215 KTB00219 KTB00220 KTB00221 KTB00222 KTB00223 KTB00224 KTB00225 KTB00226 KTB00227 KTB00228 KTB00229 KTB00230 KTB00232 KTB00233 KTB00234 KTB00235 KTB00236 KTB00237 KTB00238 KTB00240 KTB00243 KTB00244 KTB00246 KTB00247 KTB00248 KTB00249 KTB00250 KTB00251 KTB00252 KTB00253 KTB00254 KTB00255 KTB00256 KTB00257 KTB00258 KTB00259 KTB00260 KTB00261 KTB00262 KTB00263 KTB00264 KTB00265 KTB00266 KTB00267 KTB00268 KTB00269 KTB00270 KTB00271 KTB00272 KTB00273 KTB00274 KTB00275 KTB00276 KTB00277 KTB00278 KTB00279 KTB00280 KTB00281 KTB00282 KTB00283 KTB00284 KTB…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, N, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, Virgin Island, VT, WA, WI, WV, and WY. The countries of Algeria, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Egypt, El Salvador, France, Germany, Guatemala, India, Indonesia, Italy, Japan, Korea, Kuwait, Malaysia, Mexico, New Zealand, Paraguay, Philippines, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Taiwan, Turkey, United Arab Emirates.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-0353-2024: BioFire Diagnostics, LLC is recalling FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB ports. The BioFire FilmArray Torch (BioFire Torch) is an automated in vitro diagnostic (IVD) device intended for use with FDA-cleared or approved IVD BioFire FilmArray Panels. Additional Part/Reference Numbers as part of the system: - HTFA-ASY-0102: BIOFIRE TORCH Duplex. This is a plastic component that covers the BIOFIRE TORCH Modules. The BIOFIRE TORCH Duplex is only necessary if the system includes more than two modules. - HFTA-SUB-0103: BIOFIRE TORCH Module. The BIOFIRE reagent pouches are inserted into the modules.
text: The FDA logged enforcement record Z-0353-2024: BioFire Diagnostics, LLC is voluntarily recalling FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB ports. The BioFire FilmArray Torch (BioFire Torch) is an automated in vitro diagnostic (IVD) device intended for use with FDA-cleared or approved IVD BioFire FilmArray Panels. Additional Part/Reference Numbers as part of the system: - HTFA-ASY-0102: BIOFIRE TORCH Duplex. This is a plastic component that covers the BIOFIRE TORCH Modules. The BIOFIRE TORCH Duplex is only necessary if the system includes more than two modules. - HFTA-SUB-0103: BIOFIRE TORCH Module. The BIOFIRE reagent pouches are inserted into the modules. — reason: 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.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-10-17. Affected lots/codes: Model/Part Number: HTFA-ASY-0104 UDI-DI Code: 00815381020253 Serial Numbers: All serial numbers (listed below) U.S. KTB00006 KTB00007 KTB00008 KTB00009 KTB00011 KTB00012 KTB00014 KTB00015 KTB00016 KTB00017 KTB00018 KTB00019 KTB00020 KTB00021 KTB00022 KTB00023 KTB00025 KTB00026 KTB00027 KTB00029 KTB00030 KTB00031 KTB00032 KTB00033 KTB00034 KTB00035 KTB00036 KTB00037 KTB00038 KTB00039 KTB00040 KTB00041 KTB00044 KTB00045 KTB00046 KTB00053 KTB00056 KTB00058 KTB00059 KTB00060 KTB00061 KTB00062 KTB00063 KTB00064 KTB00065 KTB00066 KTB00068 KTB00069 KTB00070 KTB00071 KTB…
claim type: official_fact
review status: current
commercial influence: false
epistemic status:
  occurred: true
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: SourceCitation
  source: openFDA drug & device enforcement (recall) reports — U.S. FDA
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Devices recall, status Ongoing
  adjudicator: openFDA drug & device enforcement (recall) reports — U.S. FDA
falsifier: A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release.

FDA classified recall Z-0353-2024 as Class II
type: Claim
text: The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.
claim type: regulatory_determination
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: AdjudicativeAct
  source: U.S. FDA recall classification (openFDA enforcement)
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Class II
  adjudicator: U.S. FDA recall classification (openFDA enforcement)
falsifier: occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies.

What an FDA recall is — and is NOT
type: Claim
text: A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.
claim type: interpretation
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: false
  operative: true
grounding:
  grounding type: Interpretation
  source: Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
  source url: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
  value: a recorded enforcement action, not proof of harm or causation; not medical advice
falsifier: occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not.