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Lower risk Medical device recall · FDA · Published June 27, 2018

Biomerieux BACT/ALERT VIRTUO System R2.0 Firmware Recall: Calibration Anomaly Risk

Biomerieux recalls BACT/ALERT VIRTUO system B Units with R2.0 firmware due to potential calibration issues. Affected units may show anomalies if calibration standards aren't properly repositioned during service. Contact for remedy details.

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

🇺🇸 FDA recall #Z-0229-2019Medical deviceBiomerieux ›
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Contact the company

Recalling firmbioMerieux, Inc.100 Rodolphe St · Durham, NC 27712-9402
✎ GovInfoNow plain-language explainer

Biomerieux is recalling BACT/ALERT VIRTUO system B Units with R2.0 firmware because improper calibration standards placement during service could cause system anomalies. This affects laboratory users who rely on the system for microbial detection. Read more at govinfonow.com/recall/70717-biomerieux-bact-alert-virtuo-system-r2-0-firmware-recall-calibration.

Source Summary by GovInfoNow · govinfonow.com/recall/70717-biomerieux-bact-alert-virtuo-system-r2-0-firmware-recall-calibration · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0229-2019

Cite this page

“Biomerieux BACT/ALERT VIRTUO System R2.0 Firmware Recall: Calibration Anomaly Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70717-biomerieux-bact-alert-virtuo-system-r2-0-firmware-recall-calibration. Based on FDA recall #Z-0229-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0229-2019%22&limit=1).

The FDA announced on June 27, 2018, that Biomerieux Inc. is recalling the BACT/ALERT VIRTUO system, B Unit with Version R2.0 firmware. The hazard involves potential anomalies if calibration standards are not returned to designated locations after servicing.

How to tell if you have it

  • Brand: Biomerieux
  • Product: BACT/ALERT VIRTUO system, B Unit
  • Firmware: Version R2.0
  • Reference Number: 411661
  • UDI: 03573026369774
  • Quantity: 151 units

The hazard

The firmware allows relocation of four resident calibration standards to service cells P24-P27. If these standards are not returned to their designated locations, an anomaly may occur.

Context

GovInfoNow's records show Biomerieux Inc has 36 other recalls on record since July 12, 2017. Other recent recalls of similar products include the VITEK 2 AST-N461 Test Kit Recall (July 24, 2026), the VITEK 2 AST-N447 Kit Recall (June 4, 2026), and the VITEK 2 Gram-negative Susceptibility Cards recall (Jan. 5, 2026). Other recent recalls of similar products include the Meridian Bioscience Revogene C. difficile Test Recall (Dec. 5, 2025), the Bioporto ProNephro AKI Reagent Kit Recall (May 18, 2026), and the Abiomed Impella RP Recall (Jan. 27, 2026).

How to tell if you have this one

Check for the BACT/ALERT VIRTUO system B Unit with firmware version R2.0. Affected units have serial numbers listed in the recall notice.

  • Brand
    Biomerieux
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Worldwide - US Nationwide distribution in the states of AR, CA, CO, FL, GA, IL, IN, KS, LA, MI, MO, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SD, TN, TX, UT, VT, WV. Distributed internationally to Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, Colombia, Germany, Spain, France, United Kingdom, Hong Kong, India, Italy, Japan, South Korea, Netherlands, Portugal, Sweden, Singapore, Thailand, South Africa, Saudi Arabia, Philippines, Myanmar, Serbia, Lebanon, United Arab Emirates, Slovenia, Qatar, Costa Rica, Croatia, Panama, Estonia, Israel, Philippines, Malaysia, Brunei Darussalam, Vietnam, Kuwait.
Recall numberProduct, codes & lotsQuantity
Z-0228-2019BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaerobic microorganism growth from blood and other normally sterile body fluids.; Reference Number 411660, UDI 03573026369767, all serial numbers516 units
Z-0229-2019BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaerobic microorganism growth from blood and other normally sterile body fluids.; Reference Number 411661, UDI 03573026369774, all serial numbers151 units
Z-0230-2019BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaerobic microorganism growth from blood and other normally sterile body fluids.; Reference Number 419947, UDI 03573026509538, all serial numbers8 units
Based on the official FDA remedy

What to do — step by step

  1. Check Firmware Version

    Verify the firmware version on your BACT/ALERT VIRTUO system B Unit. If it's R2.0, it may be affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 26 states.

Alaska: nationwideAKMaine: nationwideMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: named in the noticeWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide - US Nationwide distribution in the states of AR, CA, CO, FL, GA, IL, IN, KS, LA, MI, MO, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SD, TN, TX, UT, VT, WV. Distributed internationally to Austria, Australia, Belgium, Brazil, Canada,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Michigan, Missouri, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Vermont, West Virginia.

Recall timeline

FDA terminated this recall 2.1 years after the firm started it.

1. Firm started the recall: Jun 27, 201812. FDA classified it Class II: Oct 23, 201823. Published in FDA’s Enforcement Report: Oct 31, 201834. FDA terminated the recall: Jul 21, 2020420182020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

Do I need to stop using the system immediately?

No. The recall does not require immediate discontinuation. Users can continue using the system as long as calibration standards are correctly repositioned after service.

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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-0229-2019 (June 27, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0229-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 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