Lower riskMedical device recall · FDA · Published March 6, 2019
BioFire GI Panel Recall: False Positive Results for Campylobacter and Cryptosporidium
BioFire Diagnostics recalls GI Panel devices due to elevated false positives for Campylobacter and Cryptosporidium. Affected units have expiration dates from October 2019 onward. No remedy specified in recall notice.
“BioFire GI Panel Recall: False Positive Results for Campylobacter and Cryptosporidium.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68906-biofire-gi-panel-recall-false-positive-results-for-campylobacter-and. Based on FDA recall #Z-1242-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1242-2019%22&limit=1).
The FDA announced on March 6, 2019, that BioFire Diagnostics, LLC is recalling FilmArray Gastrointestinal (GI) Panel IVD kits due to elevated rates of false positive results for Campylobacter and Cryptosporidium. The agency issued recall number Z-1242-2019 for the voluntary Class II action.
How to tell if you have it
Brand: BioFire Diagnostics
Product: FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only
REF codes: RFIT-ASY-0104, RFIT-ASY-0116
Lots with expiration date of 23 October 2019 onward
The hazard
Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified. The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.
Context
GovInfoNow's records show BioFire Diagnostics, LLC has 32 other recalls on record since March 14, 2018. Recent BioFire recalls include the Respiratory Panel 2.1 (June 24, 2026) for false negatives and the Joint Infection Panel (April 22, 2026) for false positives risk. Other recent recalls of similar products include the Biofire Defense FilmArray NGDS Warrior Panel Recall (July 16, 2026), Meridian Bioscience Revogene C. difficile Test Recall (Dec. 5, 2025), and Biomerieux VITEK 2 AST-N447 Kit Recall (June 4, 2026).
How to tell if you have this one
Check if your GI Panel has an expiration date of 23 October 2019 or later. The product is sold under BioFire Diagnostics, LLC with reference numbers RFIT-ASY-0104 or RFIT-ASY-0116.
Brand
BioFire Diagnostics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Expiration Date
Verify the expiration date on your GI Panel; affected units have dates from October 2019 onward.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 50 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide Distribution - US Nationwide in the states of: CO, IL, NJ, PA, OH, FL, KY, NE, NY, CA, WV, UT, TX, MS, OK, WI, NC, DE, IN, MN, AK, ND, GA, AR, MO, KS, HI, IA, LA, VA, SC, MT, NM, SD, AL, WY, AZ, WA, TN, OR, MI, MA, NV, MD, CT,…” 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 terminated this recall 3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1242-2019 (March 6, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1242-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.