BioFire Diagnostics, LLC recalls FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-01
Recalled Product
FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
Hazard / Issue
The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE¿ FILMARRAY¿ Gastrointestinal (GI) Panel
Issued by
FDA
Affected States: 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY
Lot/Code Info: Model/UDI-DI: RFIT-ASY-0104/00815381020116, RFIT-ASY-0116/00815381020109 using software versions prior to FLM2-SFW-0040 v2.0.3.1/BFS0001-5539 v2.0.200.10
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