Reported Sep 18, 2024 · Ongoing
FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U
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 MODULE BOXHTFA-ASY-0003HTFA-ASY-0003-WHTFA-ASY-0003U
- Lot codes and dates
- HTFA-ASY-0003
- UDI00815381020277
- Serial Numbers
197 of 197 codes
KTM01040KTM03252KTM05330KTM05411KTM05602KTM05734KTM05800KTM05810KTM05887KTM05997KTM06000KTM06003KTM06005KTM06038KTM06057KTM06063KTM06139KTM06639KTM06756KTM06870KTM06902KTM07116KTM13705KTM13710KTM13815KTM14196KTM14329KTM14357KTM14918KTM15242KTM15798KTM15801KTM15819KTM17194KTM17531KTM17570KTM17576KTM17696KTM17812KTM18083KTM18448KTM18453KTM18464KTM18559KTM19173KTM19183KTM19386KTM20255KTM20260KTM20273KTM20280KTM20296KTM20299KTM20301KTM20308KTM20314KTM20318KTM20321KTM20324KTM20325
- UDI00815381029089
- Serial Numbers
3,055 of 3,055 codes
KTM00005KTM00013KTM00033KTM00039KTM00040KTM00041KTM00044KTM00046KTM00050KTM00053KTM00054KTM00056KTM00059KTM00060KTM00064KTM00074KTM00076KTM00077KTM00080KTM00081KTM00088KTM00090KTM00105KTM00112KTM00119KTM00136KTM00138KTM00140KTM00152KTM00156KTM00175KTM00178KTM00183KTM00190KTM00194KTM00202KTM00203KTM00219KTM00227KTM00232KTM00234KTM00236KTM00238KTM00241KTM00249KTM00250KTM00251KTM00253KTM00262KTM00263KTM00265KTM00275KTM00291KTM00293KTM00295KTM00298KTM00299KTM00303KTM00307KTM00308
- Amount recalled
- 3,439
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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