FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
FDA device recall Z-2588-2023 · posted 2024-09-30 · Open, Classified
Recall details
- Recalling firm
- BioFire Diagnostics, LLC
- 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
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- PCH
- Quantity affected
- 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, W
- Date initiated
- 2023-04-25
- Date posted
- 2024-09-30
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch (K160459) | Biofire Diagnostics, LLC | 2016-04-01 |
| FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 (K143005) | Biofire Diagnostics, LLC | 2015-02-19 |
| FILMARRAY GASTROINTESTINAL (GI) PANEL (K140407) | Biofire Diagnostics | 2014-05-02 |