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Lower risk Medical device recall · FDA · Published January 26, 2024

BioFire BCID2 Panel Recall: False Candida Tropicalis Results with BD BACTEC Vials

BioFire Diagnostics recalls BCID2 Blood Culture Panel when used with specific BD BACTEC vials due to false positive Candida tropicalis results. Affected units may show incorrect fungal detection.

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

🇺🇸 FDA recall #Z-1139-2024Medical deviceBioFire Diagnostics ›
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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 recalls its BCID2 Blood Culture Identification Panel when used with certain BD BACTEC vials. This can cause false positive Candida tropicalis results, potentially leading to incorrect treatment decisions. Read more at govinfonow.com/recall/56253-biofire-bcid2-panel-recall-false-candida-tropicalis-results-with-bd.

Source Summary by GovInfoNow · govinfonow.com/recall/56253-biofire-bcid2-panel-recall-false-candida-tropicalis-results-with-bd · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1139-2024

Cite this page

“BioFire BCID2 Panel Recall: False Candida Tropicalis Results with BD BACTEC Vials.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56253-biofire-bcid2-panel-recall-false-candida-tropicalis-results-with-bd. Based on FDA recall #Z-1139-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1139-2024%22&limit=1).

The FDA announced on Jan. 26, 2024, that BioFire Diagnostics LLC is recalling its BIOFIRE Blood Culture Identification 2 (BCID2) Panel due to false positive Candida tropicalis results. The agency stated the recall affects panels used with specific BD BACTEC vial mediums.

How to tell if you have it

  • Brand: BioFire Diagnostics
  • Product: BIOFIRE Blood Culture Identification 2 (BCID2) Panel
  • Part Number: RFIT-ASY-0147
  • UDI-DI code: 00815381020338
  • Lot Numbers: All non-expired BCID2 Panel lots
  • Compatible Vials: BD BACTEC Lytic Anaerobic, Peds Plus, Plus Aerobic, Plus Anaerobic, Standard Aerobic, and Standard Anaerobic mediums

The hazard

The recall addresses a trend in false positive Candida tropicalis results on the blood culture panel when used with certain BD BACTEC vial mediums. The FDA noted that affected vials likely contain non-viable Candida tropicalis nucleic acid or DNA fragments detectable by the panel.

Context

GovInfoNow's records show BioFire Diagnostics, LLC has 32 other recalls on record since March 14, 2018. Recent BioFire recalls include a June 24, 2026 recall for the Respiratory Panel 2.1 regarding false negatives and an April 22, 2026 recall for the Joint Infection Panel involving false positives. Other recent recalls of similar products include the July 16, 2026 Biofire Defense FilmArray NGDS Warrior Panel Recall and the Oct. 17, 2025 TECHNO-PATH Multichem ID-B Recall.

How to tell if you have this one

Check if you have the BCID2 Panel used with BD BACTEC Lytic Anaerobic, Peds, Plus Aerobic, Plus Anaerobic, Standard Aerobic, or Standard Anaerobic vials. The recall affects all non-expired BCID2 Panel lots when used with these vial types.

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

What to do — step by step

  1. Check Panel Usage

    Verify if your BCID2 Panel is used with the listed BD BACTEC vial types.

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 noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto…” 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 26 days after the firm started it.

1. Firm started the recall: Jan 26, 202412. FDA classified it Class II: Feb 15, 202423. Published in FDA’s Enforcement Report: Feb 21, 202432024
  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.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Are the BCID2 Panel or BD BACTEC vials defective?

Neither the BCID2 test kits nor the BD BACTEC vials have a defect - both products are performing as intended.

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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-1139-2024 (January 26, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1139-2024 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