BioFire GI Panel Recall: False Positive Vibrio Results with Cary Blair Transport Medium
BioFire Diagnostics recalls GI test kits that may give false positive Vibrio results when used with Remel Cary Blair transport medium. Affected kits include RFIT-ASY-0116 (30 tests) and RFIT-ASY-0104 (6 tests).
Lower-risk recall
Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.
Contact the company
What happened, in plain English
BioFire Diagnostics is recalling two gastrointestinal test kits that may produce false positive results for Vibrio/Vibrio Cholerae when used with Remel Cary Blair transport medium. This could lead to incorrect diagnoses of serious infections if the test is used without proper handling. Read more at govinfonow.com/recall/55066-biofire-gi-panel-recall-false-positive-vibrio-results-with-cary.
Source Summary by GovInfoNow · govinfonow.com/recall/55066-biofire-gi-panel-recall-false-positive-vibrio-results-with-cary · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2514-2024
Cite this page
“BioFire GI Panel Recall: False Positive Vibrio Results with Cary Blair Transport Medium.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55066-biofire-gi-panel-recall-false-positive-vibrio-results-with-cary. Based on FDA recall #Z-2514-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2514-2024%22&limit=1).
Why it’s dangerous
The test may show false positive results for Vibrio or Vibrio Cholerae when the Cary Blair transport medium is used. This could lead to unnecessary treatment or missed infections if the test is not properly handled.
Who’s affected
Individuals using the BioFire GI Panel test kits with Remel Cary Blair transport medium for stool samples. Those testing for gastrointestinal infections are most at risk of incorrect results.
How to tell if you have this one
Check for product part numbers RFIT-ASY-0116 (30 test kit) or RFIT-ASY-0104 (6 test kit). The kits are affected if used with Remel Cary Blair transport medium lot numbers 743930, 769240, 712258, 782425, 732357, or 742049.
- Brand
BioFire- Category
Medical device
What to do — step by step
Check Product Details
Identify if your BioFire GI Panel kit has part numbers RFIT-ASY-0116 (30 tests) or RFIT-ASY-0104 (6 tests).
Verify Transport Medium
Confirm if you used Remel Cary Blair transport medium with the kit, as this may cause false positive results.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 50 states.
FDA distribution: “U.S.: Nationwide - AK, AL, AR, AZ, CA, CO, CT, DC, DE, 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, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, Virgin Island, VT, WA,…” 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 3 months 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
Do I need to stop using the test kit immediately?
No, the recall does not require stopping use. The kits may still be used with other transport media to avoid false positives.
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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-2514-2024 (May 16, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2514-2024 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.