Z-2588-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 20, 2023
- Initiation Date
- April 25, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 61,069
Product Description
FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
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 Pattern
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
Code Information
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