Lower riskMedical device recall · FDA · Published July 20, 2021
BioFire FilmArray BCID Panel Pouchs May Give False Negatives - Recall
BioFire Diagnostics recalls FilmArray BCID Panel product pouches with part numbers RFIT-ASY-0126/0127 that may cause false negative blood culture results due to manufacturing errors.
Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.
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Contact the company
📍Recalling firmBioFire Diagnostics, LLC515 S Colorow Dr · Salt Lake City, UT 84108-1248
“BioFire FilmArray BCID Panel Pouchs May Give False Negatives - Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62191-biofire-filmarray-bcid-panel-pouchs-may-give-false-negatives-recall. Based on FDA recall #Z-2245-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2245-2021%22&limit=1).
The FDA announced on July 20, 2021, that BioFire Diagnostics, LLC is recalling FilmArray BCID Panel Product Pouches due to potential false negative results caused by a manufacturing error. The agency classified the recall as Class II.
The recall addresses product complaints regarding false negative results, or dropouts, with the blood culture identification panel. This potential issue was caused by a pouch manufacturing error.
Context
GovInfoNow's records show BioFire Diagnostics, LLC has 32 other recalls on record since March 14, 2018. Recent brand recalls include the BioFire Respiratory Panel 2.1 (June 24, 2026), BioFire Joint Infection Panel (April 22, 2026), and BioFire Spotfire Respiratory Panel (April 1, 2026). Other recent recalls of similar products include the Biofire Defense FilmArray NGDS Warrior Panel Recall (July 16, 2026), Biomerieux VITEK 2 AST-N447 Kit Recall (June 4, 2026), and Meridian Bioscience Revogene C. difficile Test Recall (December 5, 2025).
How to tell if you have this one
Check for product pouches labeled 'FilmArray BCID Panel' with part numbers RFIT-ASY-0126 or RFIT-ASY-0127. The pouches also have unique identifiers (UDI) 00815381020086 or 00815381020093.
Brand
BioFire Diagnostics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Pouch
Look for the product pouches with part numbers RFIT-ASY-0126 or RFIT-ASY-0127 to confirm if you have the recalled items.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 6 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “U.S. Nationwide Distribution in the states of : FL, MI, NJ, OH, VA and WI. O.U.S.: None” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Michigan, New Jersey, Ohio, Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 17 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 recall does not require stopping use immediately; however, you should check if you have the affected pouches and consider using a different product if you have false negatives.
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-2245-2021 (July 20, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2245-2021 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.