Lower riskMedical device recall · FDA · Published August 8, 2019
BioFire GI Panel Recall: False negatives risk incorrect treatment
BioFire Diagnostics recalls GI Panel kits with false negative results that could lead to incorrect treatment and serious health issues. Affected kits have specific UDI and expiration dates.
Complaints have been received concerning elevated rates of false negative results while using the Gastrointestinal (GI) Panel. False negative results may lead to incorrect treatment being provided which could potentially lead to more serious health events.
Take action
Contact the company
📍Recalling firmBioFire Diagnostics, LLC515 S Colorow Dr · Salt Lake City, UT 84108-1248
“BioFire GI Panel Recall: False negatives risk incorrect treatment.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67244-biofire-gi-panel-recall-false-negatives-risk-incorrect-treatment. Based on FDA recall #Z-1451-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1451-2020%22&limit=1).
The FDA announced on 2019-08-08 that BioFire Diagnostics, LLC is recalling its FilmArray Gastrointestinal (GI) Panel due to false negative results. The agency stated these errors could lead to incorrect treatment and serious health events.
How to tell if you have it
Brand: BioFire Diagnostics
Product: FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
UPC: 00815381020116
Kit Lot: 0537319 / Pouch Lot: 681619
Pouch Lot Date of Expiration: 2020-05-30
Units affected: 23 kits (690 pouches)
Distribution: US: KY, IL, NJ, MS
The hazard
The FDA reported complaints concerning elevated rates of false negative results while using the Gastrointestinal (GI) Panel. The agency said false negative results may lead to incorrect treatment being provided which could potentially lead to more serious health events.
Context
GovInfoNow's records show BioFire Diagnostics, LLC has 32 other recalls on record since 2018-03-14. Other recent recalls of similar products include BioFire Respiratory Panel 2.1 (2026-06-24), BioFire Joint Infection Panel Recall (2026-04-22), and BioFire Spotfire Respiratory Panel Recall (2026-04-01). Other recent recalls of similar products include Biofire Defense FilmArray NGDS Warrior Panel Recall (2026-07-16), Biomerieux VITEK 2 AST-N447 Kit Recall (2026-06-04), and Biomerieux VITEK 2 AST-N461 Test Kit Recall (2026-07-24).
How to tell if you have this one
Check for the UDI code (01)00815381020116 on the kit packaging. The pouch expiration date is May 30, 2020.
Brand
BioFire Diagnostics
Product
FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Expiration
Verify the pouch expiration date is May 30, 2020.
Review UDI Code
Look for the unique device identifier (UDI) (01)00815381020116 on the kit packaging.
Where it went and when
Where it was distributed
Distributed in 4 states.
Listed by the agency
Not listed
FDA distribution: “US: KY, IL, NJ, MS” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Illinois, Kentucky, Mississippi, New Jersey.
Recall timeline
FDA terminated this recall 2.7 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-1451-2020 (August 8, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1451-2020 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.