FDA-Device2023-09-20Class II
FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
Hazard
The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE¿ FILMARRAY¿ Gastrointestinal (GI) Panel
Sold states
US:DE, AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. OUS: AD, AE, AI, AR, AT, AU, BD, BE, BF, BG, BH, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EE, ES, FI, FR, GA, GB, GE, GH, GM, GR, GU, HK, HU, IC, ID, IE, IL, IN, IQ, IT, JP, KE, KR, KW, LV, MO, MX, MY, NL, NO, NP, NZ, PG, PH, PL, PT, QA, RS, SA, SE, SG, SI, TH, TN, TR, TW, VN, ZA, ZW
Affected count
61,069
Manufactured in
515 S Colorow Dr, Salt Lake City, UT, United States
Products
FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2588-2023Don't want to check this manually?
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