BioFire recalls FilmArray BCID Panel (RFIT-ASY-0126) used with specific BACT/ALERT blood culture bottles. False positive Proteus results may cause improper antibiotic treatment. Affected units have UDI: 00815381020086.
There is an increased risk of false positive Proteus results when using the Film Array Blood Culture Identification Panel (BCID) in vitro diagnostic test of blood cultures used in conjunction with specific media types. False positive Proteus results from this test may lead to patients receiving improper antibiotic treatment until culture results are available (within 24-48 hours).
Take action
Contact the company
📍Recalling firmBioFire Diagnostics, LLC515 S Colorow Dr · Salt Lake City, UT 84108-1248
“BioFire FilmArray BCID Panel Recall: False Positive Proteus Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65957-biofire-filmarray-bcid-panel-recall-false-positive-proteus-results-risk. Based on FDA recall #Z-2295-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2295-2020%22&limit=1).
BioFire Diagnostics, LLC recalled FilmArray BCID Panels used with specific BACT/ALERT blood culture bottles due to an increased risk of false positive Proteus results, the FDA announced on Jan. 22, 2020.
Lot Code Condition: All lots with expiration dates of September 19, 2020 and beyond
Units Affected: 18,501 kits
The hazard
The recall addresses an increased risk of false positive Proteus results when using the FilmArray Blood Culture Identification Panel (BCID) in vitro diagnostic test with specific media types. False positive Proteus results from this test may lead to patients receiving improper antibiotic treatment until culture results are available within 24-48 hours.
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 recall (June 24, 2026) for false negatives in PCR tests and the Joint Infection Panel Recall (April 22, 2026) involving a false positives risk. Other recent recalls of similar products include the Biofire Defense FilmArray NGDS Warrior Panel Recall (July 16, 2026), the Biomerieux VITEK 2 AST-N447 Kit Recall (June 4, 2026), and the Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026).
How to tell if you have this one
Check if your FilmArray BCID Panel has the UDI code 00815381020086 and was used with BACT/ALERT blood culture bottles (410851, 410852, 410853, or 259790). The product was sold with expiration dates from September 19, 2020 onward.
Brand
BioFire
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austria, Australia, Azerbaijan, Belgium, Bosnia-Herz., Botswana, Brazil, Bulgaria, Burkina Faso, Canada, Chile, Columbia, Costa Rica, Croatia, Czech Republic, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, France, Gabon, Georgia, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Ivory Coast, Japan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Oman, Pakistan, Panama, Paraguay, Peru, Phillipines, Poland, Portugal, Romania, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Sitzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, United Arab Emirates, Vietnam.
Recall number
Product, codes & lots
Quantity
Z-2295-2020
FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description: 410851/BACT/ALERT¿ FA Plus 410852/BACT/ALERT¿ FN Plus 410853/BACT/ALERT¿ PF Plus 259790/BACT/ALERT¿ SN Product Usage: is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.; All lots of BioFire BCID Panel used with BACT/ALERT¿ blood culture bottles with expiration dates of September 19, 2020 and beyond.
18,501 kits
Z-2296-2020
FilmArray BCID Panel, RFIT-ASY-0127, 6, Rx Only, CE, IVD, UDI: 00815381020093 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description: 410851/BACT/ALERT¿ FA Plus 410852/BACT/ALERT¿ FN Plus 410853/BACT/ALERT¿ PF Plus 259790/BACT/ALERT¿ SN Product Usage: is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.; All lots of BioFire BCID Panel used with BACT/ALERT¿ blood culture bottles with expiration dates of September 19, 2020 and beyond.
5,020 kits
Based on the official FDA remedy
What to do — step by step
Check Panel UDI
Look for the UDI code 00815381020086 on the FilmArray BCID Panel.
Verify Blood Culture Bottles
Confirm you used the panel with BACT/ALERT blood culture bottles with catalog numbers 410851, 410852, 410853, or 259790.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austria, Australia, Azerbaijan, Belgium, Bosnia-Herz., Botswana, Brazil, Bulgaria, Burkina Faso, Canada, Chile, Columbia, Costa Rica, Croatia, Czech…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 15 months 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-2295-2020 (January 22, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2295-2020 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.