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U.S. Department of Health and Human Services

Medical Device Recalls
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Related Medical Device Recalls
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Z-0148-2027 - Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kits). Verificati... 2 10/13/2026 FEI # 3002773840
BioFire Diagnostics, LLC
Z-0150-2027 - Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135 (6 Kit) Software Version: N/A Product De... 2 10/13/2026 FEI # 3002773840
BioFire Diagnostics, LLC
Z-0149-2027 - Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel plus Model/Catalog Number: RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit) Software Version: N/A Product Descriptio... 2 10/13/2026 FEI # 3002773840
BioFire Diagnostics, LLC
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