BioFire GI Panel Recall: False Norovirus Results Risk
BioFire Diagnostics recalls GI panels with potential for false positive Norovirus results. Affected kits include RFIT-ASY-0116 (30 tests) and RFIT-ASY-0104 (6 tests).
Lower-risk recall
Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.
Contact the company
What happened, in plain English
BioFire Diagnostics is recalling two gastrointestinal test kits because they may produce false positive results for Norovirus. This could lead to incorrect diagnoses and unnecessary treatments if used without proper verification. Read more at govinfonow.com/recall/56239-biofire-gi-panel-recall-false-norovirus-results-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/56239-biofire-gi-panel-recall-false-norovirus-results-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1140-2024
Cite this page
“BioFire GI Panel Recall: False Norovirus Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56239-biofire-gi-panel-recall-false-norovirus-results-risk. Based on FDA recall #Z-1140-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1140-2024%22&limit=1).
Why it’s dangerous
The GI panels may generate false positive Norovirus results, which could lead to incorrect patient diagnoses. This might cause unnecessary treatments or delays in proper care if not addressed.
Who’s affected
Laboratories and healthcare facilities using the recalled GI panels for testing. Those most at risk are labs that rely on these kits for patient diagnostics.
How to tell if you have this one
Check for part numbers RFIT-ASY-0116 (30 test kit) or RFIT-ASY-0104 (6 test kit) on the product packaging. The recall covers kits sold by BioFire Diagnostics.
- Brand
BioFire Diagnostics- Category
Medical device
What to do — step by step
Check Product Details
Verify the part number on the packaging to confirm if it matches RFIT-ASY-0116 (30 test kit) or RFIT-ASY-0104 (6 test kit).
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 50 states.
FDA distribution: “Worldwide - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, 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, Puerto Rico, RI,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 26 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Are there any safety risks from using the recalled kits?
The recall indicates a risk of false positive results, but no immediate safety hazards like injury or death are mentioned.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1140-2024 (January 26, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1140-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.