FilmArray Gastrointestinal (GI) Panel recallZ-2588-2023 · BioFire Diagnostics, LLC · initiated Apr 25, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from BioFire Diagnostics, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
FDA root cause category: Software design
What the company is doing
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 [email protected] Questions or concerns can be directed to Technical Support at [email protected] or via telephone by dialing 1.800.735.6544 and selecting option 5.
Recall details
- Recall number
- Z-2588-2023
- Status
- Open, Classified
- Initiated by the company
- Apr 25, 2023
- Posted by the FDA
- Sep 30, 2024
- Recalling firm
- BioFire Diagnostics, LLC
- Quantity
- 61,069
- Product code
- PCH
- FDA submissions
- K140407, K160459, K143005
- 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
Product description
FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- FilmArray® Gastrointestinal (GI) Panel RFIT-ASY-0116Biofire Diagnostics, LLC · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System6 recalls2 deaths24 reports
- FilmArray® Gastrointestinal (GI) Panel RFIT-ASY-0104Biofire Diagnostics, LLC · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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