Reported Aug 18, 2021 · Terminated

Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License…

Beckman Coulter, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Beckman Coulter, Inc. · 11800 Sw 147th Ave · Miami, FL · 33196-2500

Is this the product you have?

  • Kaluza
  • C Flow Cytometry Software Versions
    • 1.0*
    • 1.1.1 and 1.1.2
  • KitsC10574 - 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
Lot codes and dates
  • Versions
    • 1.0
    • 1.1.1 and 1.1.2
Amount recalled
1,085 (482 US & 603 OUS)

Where it was sold

Why it was recalled

Software anomalies that may lead to the generation of erroneous results.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 2, 2026 · Data as of Sep 19, 6:22 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.