BioFire recalls BCID2 Panel (REF RFIT-ASY-0147) due to potential false negatives in blood culture tests. Affected units have pouches with wrong packaging material. Contact for remedy.
Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel (BCID) instead of OPP from BCID2 Panel.
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Contact the company
📍Recalling firmBioFire Diagnostics, LLC515 S Colorow Dr · Salt Lake City, UT 84108-1248
✎ GovInfoNow plain-language explainer
BioFire is recalling its BCID2 Blood Culture Identification Panel because some units have pouches made with the wrong packaging material, which can cause false negative results in blood culture tests. This means the test might incorrectly show no infection when one exists. Read more at govinfonow.com/recall/62585-biofire-bcid2-panel-recall-false-negative-blood-culture-results-risk.
“BioFire BCID2 Panel Recall: False Negative Blood Culture Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62585-biofire-bcid2-panel-recall-false-negative-blood-culture-results-risk. Based on FDA recall #Z-1903-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1903-2021%22&limit=1).
The FDA announced on May 10, 2021, that BioFire Diagnostics, LLC voluntarily recalled the BioFire BCID2 Panel due to elevated false negative results. The recall affects 870 kits distributed nationwide in the United States.
How to tell if you have it
BioFire BCID2 Panel, REF RFIT-ASY-0147
UPC 00815381020338
Pouch Lot# 11YA20
Kit Lot# 2039020
The hazard
The recall was issued because pouches contained OPP from the FilmArray Blood Culture Identification Panel (BCID) instead of the correct BCID2 Panel, leading to elevated rates of false negative results. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show BioFire Diagnostics, LLC has had 32 other recalls on record since March 14, 2018. Other recent recalls include the BioFire Respiratory Panel 2.1 (June 24, 2026), the BioFire Joint Infection Panel (April 22, 2026), and the BioFire Spotfire Respiratory Panel (April 1, 2026). Other recent recalls of similar products include the Biofire Defense FilmArray NGDS Warrior Panel (July 16, 2026), the Biomerieux VITEK 2 AST-N447 Kit (June 4, 2026), and the Biomerieux VITEK 2 AST-N461 Test Kit (July 24, 2026).
How to tell if you have this one
Check for the product code REF RFIT-ASY-0147 on the panel. Look for pouch lot number 11YA20 and kit lot number 2039020. The unique device identifier (UDI) is (01)00815381020338.
Brand
BioFire
Product
BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Panel Details
Verify the product code REF RFIT-ASY-0147, pouch lot number 11YA20, and kit lot number 2039020 on the panel.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US nationwide distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 19 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-1903-2021 (May 10, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1903-2021 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.