Reported Nov 29, 2023 · Ongoing
FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen…
BioFire Diagnostics, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BioFire Diagnostics, LLC · 515 S Colorow Dr · Salt Lake City, UT · 84108-1248
Is this the product you have?
- 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-0102BIOFIRE 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-0103BIOFIRE TORCH Module. The BIOFIRE reagent pouches are inserted into the modules
- Lot codes and dates
- Model/Part NumberHTFA-ASY-0104
- UDI-DI Code00815381020253
- Serial NumbersAll serial numbers (listed below) U.S.O.U.S.
2,207 of 2,207 codes
KTB00006KTB00007KTB00008KTB00009KTB00011KTB00012KTB00014KTB00015KTB00016KTB00017KTB00018KTB00019KTB00020KTB00021KTB00022KTB00023KTB00025KTB00026KTB00027KTB00029KTB00030KTB00031KTB00032KTB00033KTB00034KTB00035KTB00036KTB00037KTB00038KTB00039KTB00040KTB00041KTB00044KTB00045KTB00046KTB00053KTB00056KTB00058KTB00059KTB00060KTB00061KTB00062KTB00063KTB00064KTB00065KTB00066KTB00068KTB00069KTB00070KTB00071KTB00072KTB00073KTB00074KTB00075KTB00076KTB00077KTB00078KTB00079KTB00082KTB00083
KTB1,401 of 1,401 codes
KTB00001KTB00002KTB00003KTB00004KTB00005KTB00013KTB00028KTB00042KTB00049KTB00050KTB00051KTB00054KTB00055KTB00057KTB00067KTB00081KTB00097KTB00098KTB00099KTB00100KTB00102KTB00104KTB00106KTB00109KTB00111KTB00112KTB00113KTB00114KTB00116KTB00117KTB00118KTB00156KTB00157KTB00158KTB00162KTB00164KTB00166KTB00167KTB00168KTB00169KTB00170KTB00171KTB00180KTB00181KTB00192KTB00204KTB00214KTB00216KTB00217KTB00239KTB00288KTB00300KTB00304KTB00311KTB00315KTB00321KTB00325KTB00327KTB00343KTB00346
- Amount recalled
- 5,406 systems
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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