FILMARRAY Gastrointestinal recall
FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
Why was FILMARRAY Gastrointestinal recalled?
The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE¿ FILMARRAY¿ Gastrointestinal (GI) Panel
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
- Recalling firm
- BioFire Diagnostics, LLC
- Quantity
- 61,069
- 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
- Recall date
- September 20, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)