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Lower risk Medical device recall · FDA · Published October 17, 2023

BioFire BCID2 Panel Recall: Control Panel Issues May Cause False Negatives

BioFire Diagnostics recalls BCID2 Blood Culture Panel REF RFIT-ASY-0147 with Maine Molecular Quality Controls control panels. Affected units may show C. tropicalis as 'Not Detected' due to assay errors. Contact for remedy.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0451-2024Medical deviceBioFire ›
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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 Diagnostics is recalling a specific blood culture identification panel that may show false negative results for C. tropicalis infections. This could lead to missed diagnoses if the control panel isn't properly calibrated. Read more at govinfonow.com/recall/57057-biofire-bcid2-panel-recall-control-panel-issues-may-cause-false.

Source Summary by GovInfoNow · govinfonow.com/recall/57057-biofire-bcid2-panel-recall-control-panel-issues-may-cause-false · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0451-2024

Cite this page

“BioFire BCID2 Panel Recall: Control Panel Issues May Cause False Negatives.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57057-biofire-bcid2-panel-recall-control-panel-issues-may-cause-false. Based on FDA recall #Z-0451-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0451-2024%22&limit=1).

The FDA announced on 2023-10-17 that BioFire Diagnostics, LLC is recalling the BIOFIRE Blood Culture Identification 2 (BCID2) Panel due to potential false negative results for C. tropicalis infections. The agency stated that quality control testing may need amendment because affected control panels can lead to the pathogen being reported as not detected. Owners should contact BioFire Diagnostics for further instructions.

How to tell if you have it

  • Brand: BioFire
  • Product: BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147
  • Used with: Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Control Panel M416
  • Control Panel Reference: FLM1-PRT-0251; REF/UDI-DI: RFIT-ASY-0147/00815381020338
  • Lot Code: FLM1-PRT-0251-16 and prior
  • Units Affected: 32,910

The hazard

According to the FDA, routine quality control testing of the affected blood culture identification panel with the affected control panel may need to be amended. This is due to control panel and instrument characteristic changes that cause C. tropicalis to be amplified in some test runs but reported as "Not Detected" because the assay amplicon Tm is outside the acceptable limit for calling positive results.

Context

GovInfoNow's records show BioFire Diagnostics, LLC has 32 other recalls on record since 2018-03-14. Recent BioFire recalls include the Respiratory Panel 2.1 recall on 2026-06-24 for false negatives, the Joint Infection Panel Recall on 2026-04-22 for false positives, and the Spotfire Respiratory Panel Recall on 2026-04-01 for false negatives. Other recent recalls of similar products include the Biofire Defense FilmArray NGDS Warrior Panel Recall (2026-07-16), the Meridian Bioscience Revogene C. difficile Test Recall (2025-12-05), and the TECHNO-PATH Multichem ID-B Recall (2025-10-17).

How to tell if you have this one

Check for the BioFire BCID2 Panel reference number RFIT-ASY-0147 on the product label. The affected control panel is the Maine Molecular Quality Controls M416 (FLM1-PRT-0251) used with this panel.

  • Brand
    BioFire
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Panel Reference

    Verify the BioFire BCID2 Panel has reference number RFIT-ASY-0147 on its label.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 50 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide Distribution: US (nationwide): DE, OH, NY, IL, KY, FL, GA, KS, CA, WI, NC,, AK, PA, MN, ND, IN, AR, CO, UT, TX, AL, NJ, MD, SD, LA, OR, MA, ID, NE, MT, VA, IA, MO, WV, TN, MI, WY, SC, AZ, WA, NH, OK, HI, MS, DC, VT, CT, NM, RI,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 57 days after the firm started it.

1. Firm started the recall: Oct 17, 202312. FDA classified it Class II: Dec 1, 202323. Published in FDA’s Enforcement Report: Dec 13, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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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-0451-2024 (October 17, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0451-2024 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA