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Lower risk Medical device recall · FDA · Published June 19, 2024

BioFire BCID2 Panel Recall: False Serratia marcescens Results Risk

BioFire recalls BCID2 Blood Culture Panel for FILMARRAY Systems when used with specific culture media lots. False positive Serratia marcescens results may lead to incorrect patient treatment.

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

🇺🇸 FDA recall #Z-2456-2024Medical deviceBioFire ›
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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 for FILMARRAY Systems. Using this panel with certain culture media bottles can cause false positive results for Serratia marcescens, which might lead to inappropriate patient treatment. Read more at govinfonow.com/recall/54788-biofire-bcid2-panel-recall-false-serratia-marcescens-results-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/54788-biofire-bcid2-panel-recall-false-serratia-marcescens-results-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2456-2024

Cite this page

“BioFire BCID2 Panel Recall: False Serratia marcescens Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54788-biofire-bcid2-panel-recall-false-serratia-marcescens-results-risk. Based on FDA recall #Z-2456-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2456-2024%22&limit=1).

The FDA announced on June 19, 2024, that BioFire Diagnostics LLC is recalling the BIOFIRE Blood Culture Identification 2 (BCID2) Panel due to potential false positive results for Serratia marcescens. The agency stated this hazard may lead to inappropriate changes in patient therapy.

How to tell if you have it

  • Brand: BioFire
  • Product: BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147
  • Compatible Systems: FILMARRAY Systems
  • Affected Media Bottles: BACT/ALERT FA PLUS, REF: 410851 and BACT/ALERT PF PLUS, REF: 410853
  • BCID2 UDI-DI: 00815381020338
  • BACT/ALERT FA PLUS Lots/Expirations: 0004101638/3/20/2024, 0004101930/7/28/2024, 0004102026/9/4/2024, 0004102408/2/16/2025, 0004102996/9/24/2025, 0004102946/8/29/2025, 0004102956/9/17/2025, 0004102998/9/24/2025
  • BACT/ALERT PF PLUS Lots/Expirations: 0004101718/4/24/2024, 0004101790/6/1/2024, 0004101958/8/3/2024, 0004102452/3/3/2025, 0004102964/9/19/2025
  • Units Affected: 99,822

The hazard

According to the FDA, if the panel is used with specific lots of culture media bottles, false positive Serratia marcescens results may occur due to increased levels of non-viable organism targets. This false positive result may lead to an inappropriate change in patient therapy.

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 of the Respiratory Panel 2.1 for false negative risks and an April 22, 2026 recall of the Joint Infection Panel for false positive risks. Other recent recalls of similar products include the July 16, 2026 Biofire Defense FilmArray NGDS Warrior Panel Recall and the July 24, 2026 Biomerieux VITEK 2 AST-N461 Test Kit Recall.

How to tell if you have this one

Check if your BCID2 panel has the reference number RFIT-ASY-0147 and is used with BACT/ALERT FA PLUS (REF: 410851) or PF PLUS (REF: 410853) culture media bottles. The affected media lots have specific expiration dates listed in the recall notice.

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

What to do — step by step

  1. Check Panel and Media Lots

    Verify your BCID2 panel reference number is RFIT-ASY-0147 and that you're using specific culture media lots listed in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 44 states.

Alaska: named in the noticeAKMaine: nationwideMEVermont: nationwideVTNew 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: nationwideRIMassachusetts: 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: nationwideUTColorado: 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: nationwideDEArizona: 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: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide - US Nationwide distribution including in the states of FL, IL, KY, CO, KS, NC, AK, NY, ND, CA, TX, MD, GA, OH, WI, SD, LA, MT, VA, IA, MO, MA, WV, NE, OK, AZ, OR, SC, MI, IN, ID, TN, WA, NM, NJ, AR, AL, MN, NH, NV, PA, WY, MS,…” 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, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, 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, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 49 days after the firm started it.

1. Firm started the recall: Jun 19, 202412. FDA classified it Class II: Jul 31, 202423. Published in FDA’s Enforcement Report: Aug 7, 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.

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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-2456-2024 (June 19, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2456-2024 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