FilmArray TORCH
Medical device recall Z-0353-2024. Published in FDA’s Enforcement Report on Nov 29, 2023.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 29, 2023. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 51 states named
- 5,406 systems how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
5,406 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,997 characters
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…
FDA’s list runs to 48,777 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
51 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 17, 2023.
- FDA classified it on Nov 20, 2023.
- FDA’s Enforcement Report published it on Nov 29, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- BioFire Diagnostics, LLC, of Salt Lake City, UT.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 48,777 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.