FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
- Company
- Biofire Diagnostics, Llc
- Recall Initiated
- April 25, 2023
- Posted
- September 30, 2024
- Recall Number
- Z-2588-2023
- Quantity
- 61,069
- Firm Location
- Salt Lake City, UT
Reason for Recall
The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
Distribution
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
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
Root Cause
Software design
Action Taken
On 4/25/23 correction notices were mailed to customers who were told to update the GI pouch module software. Instructions for installation can be downloaded here: https://www.biofiredx.com/e-labeling/ITIFA20GI21. This technical note and download cannot be opened via Firefox browser; please use a different browser. Once the pouch module software has been updated, complete and return the webform located at: https://www.biofiredx.com/gisoftware-5747 or return the acknowledgement form via email to FCA5747@biomerieux.com Questions or concerns can be directed to Technical Support at biofiresupport@biomerieux.com or via telephone by dialing 1.800.735.6544 and selecting option 5.