FDA-Device2024-08-07Class II
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Media Bottles: BACT/ALERT FA PLUS, REF: 410851, and BACT/ALERT PF PLUS, REF: 410853
BioFire Diagnostics, LLC
Hazard
If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an increased level of non-viable organism from serratia marcescens targets in culture media bottles, false positive result may lead to an inappropriate change in patient therapy.
Sold states
Worldwide - US Nationwide distribution including in the states of FL, IL, KY, CO, KS, NC, AK, NY, ND, CA, TX, MD, GA, OH, WI, SD, LA, MT, VA, IA, MO, MA, WV, NE, OK, AZ, OR, SC, MI, IN, ID, TN, WA, NM, NJ, AR, AL, MN, NH, NV, PA, WY, MS, CT and the countries of AE, AM, AR, AT, BA, BG, BH, BN, BR, CA, CH, CI, CK, CN, CO, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GA, GB, GE, GR, GT, HR, HU, IL, IN, IQ, IS, IT, JO, JP, KK, KR, KW, LB, LT, LV, MK, MM, MX, MY, NG, NO, NW, OM, PA, PH, PK, PL, PT, QA, RO, RS, SA, SI, TN, TR, TW, UG, UY, VN, WF.
Affected count
99,822
Manufactured in
515 S Colorow Dr, N/A, Salt Lake City, UT, United States
Products
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Media Bottles: BACT/ALERT FA PLUS, REF: 410851, and BACT/ALERT PF PLUS, REF: 410853
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2456-2024Don't want to check this manually?
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