BioFire Diagnostics recalls specific FilmArray Meningitis/Encephalitis panels due to potential false positives for HSV-1. Affected kits may require replacement to avoid incorrect test results.
Firm identified an issue in the manufacturing process which might contribute to elevated rates of false positive results for HSV-1 while using the ME Panel. Only specific kits are affected.
Take action
Contact the company
📍Recalling firmBioFire Diagnostics, LLC515 S Colorow Dr · Salt Lake City, UT 84108-1248
✎ GovInfoNow plain-language explainer
BioFire Diagnostics is recalling specific FilmArray Meningitis/Encephalitis (ME) panels that could produce false positive results for HSV-1. This means the test might incorrectly indicate a herpes virus infection when none exists, which could lead to unnecessary treatments or anxiety. Read more at govinfonow.com/recall/69892-biofire-filmarray-meningitis-panel-false-positive-risk-recall.
“BioFire FilmArray Meningitis Panel False Positive Risk - Recall.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69892-biofire-filmarray-meningitis-panel-false-positive-risk-recall. Based on FDA recall #Z-0446-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0446-2019%22&limit=1).
BioFire Diagnostics, LLC voluntarily recalled FilmArray Meningitis/Encephalitis (ME) Panels due to a manufacturing issue that may cause false positive results for HSV-1, according to the FDA. The Food and Drug Administration announced the recall on September 10, 2018.
How to tell if you have it
Brand: BioFire Diagnostics
Product: FilmArray Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray
Outer Kit Box P/N: RFIT-LBL-0140
UPC: 00815381020123
Kit Lot No.: 580818, 584418
ME Pouch Lot No.: 892018, 896018
Kit Expiration Date: 4/2/2019, 4/5/2019
The hazard
The manufacturer identified an issue in the manufacturing process that might contribute to elevated rates of false positive results for HSV-1 while using the ME Panel. Only specific kits are affected.
Context
GovInfoNow's records show BioFire Diagnostics, LLC has 32 other recalls on record since March 14, 2018. Other recent recalls of similar products include BioFire Respiratory Panel 2.1 (June 24, 2026), BioFire Joint Infection Panel Recall (April 22, 2026), and BioFire Spotfire Respiratory Panel Recall (April 1, 2026).
How to tell if you have this one
Check for the outer kit box with part number RFIT-LBL-0140 and panel reference RFIT-ASY-0118. The kit lot number on the box should be 580818 or 584418, and the expiration date is before April 5, 2019.
Look for the lot number on the outer kit box, which should be 580818 or 584418 for affected kits.
Contact Manufacturer
If you have the affected kit, contact BioFire Diagnostics for instructions on how to return or replace it.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 10 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide Distribution - US Nationwide in the states of: CA DC, FL, IN, KY, MN, MO, NB, NJ, OH, TX and WI. International: Canada, Columbia and Mexico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, District of Columbia, Florida, Indiana, Kentucky, Minnesota, Missouri, New Jersey, Ohio, Texas, Wisconsin.
Recall timeline
FDA terminated this recall 2.6 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-0446-2019 (September 10, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0446-2019 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.