BioFire FilmArray GI Panel Recall: False Negative Risk
BioFire Diagnostics recalls FilmArray GI Panel kits with possible false negative results due to manufacturing issues. Affected kits include specific lot numbers and model.
Lower-risk recall
Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.
Contact the company
What happened, in plain English
BioFire Diagnostics is recalling its FilmArray Gastrointestinal (GI) Panel kits because a manufacturing issue could cause false negative results. This means the test might incorrectly show no infection when one is present, potentially leading to missed diagnoses. Read more at govinfonow.com/recall/58778-biofire-filmarray-gi-panel-recall-false-negative-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/58778-biofire-filmarray-gi-panel-recall-false-negative-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1392-2023
Cite this page
“BioFire FilmArray GI Panel Recall: False Negative Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58778-biofire-filmarray-gi-panel-recall-false-negative-risk. Based on FDA recall #Z-1392-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1392-2023%22&limit=1).
Why it’s dangerous
The manufacturing issue causes the GI Panel to sometimes give false negative results, meaning infections could be missed. This happens because the test might not detect the presence of certain pathogens when they are actually there.
Who’s affected
Healthcare providers using the FilmArray GI Panel kits for testing are likely affected. Those who have the specific lot numbers (Pouch Lot# 2N3R22 / Kit Lot# 2160422) are most at risk.
How to tell if you have this one
Check the pouch lot number (2N3R22) and kit lot number (2160422) on the packaging. The product is sold under the FilmArray Systems brand with the reference number RFIT-ASY-0116.
- Brand
BioFire Diagnostics- Category
Medical device
What to do — step by step
Check Product Lot Numbers
Look for pouch lot number 2N3R22 and kit lot number 2160422 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 10 states.
FDA distribution: “US Nationwide distribution in the states of AR, CA, DC, IL, KS, LA, MN, NC, NY, OK, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arkansas, California, District of Columbia, Illinois, Kansas, Louisiana, Minnesota, New York, North Carolina, Oklahoma, Wisconsin.
Recall timeline
FDA published this recall 49 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
Is there a risk of serious injury from this panel?
No, the hazard is limited to potential false negative results, which do not cause physical harm.
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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-1392-2023 (March 8, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1392-2023 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.