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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 5 of 5 Results
510(K) Number: K140407
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FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Softwar... 2 09/30/2024 FEI # 3002773840
BioFire Diagnostics, LLC
FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit) 2 04/14/2023 FEI # 3002773840
BioFire Diagnostics, LLC
In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116 2 03/15/2023 FEI # 3002773840
BioFire Diagnostics, LLC
FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE I... 2 03/06/2020 FEI # 3002773840
BioFire Diagnostics, LLC
FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104,... 2 04/27/2019 FEI # 3002773840
BioFire Diagnostics, LLC
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