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Lower risk Medical device recall · FDA · Published June 23, 2021

Beckman Coulter Kaluza C Software Recalled for Erroneous Results

Beckman Coulter recalls Kaluza C Flow Cytometry Software versions 1.0, 1.1.1, and 1.1.2 kits that may generate erroneous results. Affected users should contact for updates.

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

🇺🇸 FDA recall #Z-2241-2021Medical deviceBeckman Coulter ›
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Contact the company

Recalling firmBeckman Coulter, Inc.11800 Sw 147th Ave · Miami, FL 33196-2500
✎ GovInfoNow plain-language explainer

Beckman Coulter is recalling specific versions of Kaluza C Flow Cytometry Software that could produce incorrect results. This affects users who have the listed software licenses and programs. The issue may lead to inaccurate data, which could impact research or testing outcomes. Read more at govinfonow.com/recall/62311-beckman-coulter-kaluza-c-software-recalled-for-erroneous-results.

Source Summary by GovInfoNow · govinfonow.com/recall/62311-beckman-coulter-kaluza-c-software-recalled-for-erroneous-results · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2241-2021

Cite this page

“Beckman Coulter Kaluza C Software Recalled for Erroneous Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62311-beckman-coulter-kaluza-c-software-recalled-for-erroneous-results. Based on FDA recall #Z-2241-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2241-2021%22&limit=1).

The FDA announced on June 23, 2021, that Beckman Coulter, Inc. is recalling Kaluza C Flow Cytometry Software versions 1.0*, 1.1.1 and 1.1.2 due to software anomalies that may lead to the generation of erroneous results. This voluntary Class II recall affects 1,085 units distributed worldwide.

How to tell if you have it

  • Brand: Beckman Coulter
  • Product: Kaluza C Flow Cytometry Software Versions 1.0*, 1.1.1 and 1.1.2
  • Kits: C10574 - Kaluza C Single Perpetual License, C10575 - Kaluza C Single User 1-year License, C10576 - Kaluza C 10 User Network License, C10577 - Kaluza C 5 User Network License, C10578 - Kaluza C Single Perpetual Educational License, C10579 - Kaluza C Single User 1-year Educational License, C10580 - Kaluza C 10 User Network Educational License, C10581 - Kaluza C 5 User Network Educational License and C21166 - Kaluza C Program DVD v1.0

The hazard

According to the FDA, software anomalies in the recalled products may lead to the generation of erroneous results.

Context

GovInfoNow's records show Beckman Coulter, Inc. has 133 other recalls on record since June 20, 2017. Other recent recalls include DxC 500 AU Clinical Chemistry Analyzers (Sept. 2, 2026), DxC 500i Modules with Software 1.5 (July 15, 2026), and MicroScan LabPro V5.03 Panel Update 11 DVD Kit (June 26, 2026). Similar recent recalls of similar products include REMISOL Advance Software Issue (April 29, 2026) and Roche cobas pro integrated solutions recall (Jan. 20, 2026).

How to tell if you have this one

Check if you have Kaluza C Flow Cytometry Software versions 1.0, 1.1.1, or 1.1.2 with license kits C10574 through C10581 or C21166. These versions were sold starting from the date of the recall announcement.

  • Brand
    Beckman Coulter
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify your Kaluza C software version by checking the product documentation or license files.

  2. Contact Manufacturer

    Reach out to Beckman Coulter for guidance on whether your software version is affected and next steps.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 35 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: 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: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: 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: nationwideMOKentucky: nationwideKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: 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: 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 distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV, and Hawaii. The…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Nebraska, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 5 years after the firm started it.

1. Firm started the recall: Jun 23, 202112. FDA classified it Class II: Aug 11, 202123. Published in FDA’s Enforcement Report: Aug 18, 202134. FDA terminated the recall: Jul 2, 2026420212026
  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 software immediately?

The recall does not require immediate discontinuation; users can continue using the software but should check for updates.

How can I confirm if my software is part of the recall?

Check your license kit number and software version against the list provided in the recall notice.

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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-2241-2021 (June 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2241-2021 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.
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