# FDA recall Z-2241-2021

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2021-06-23.

## 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

## Reason for recall

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

## 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 countries of Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Canada, China, Czech Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Israel, Italy, Kenya, Korea, Kuwait, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Portugal, Reunion, Saudi Arabia, Slovakia, South Africa, Sweden, Switzerland, Taiwan, Thailand, Tunisia, U.A.E, Ukraine, United Kingdom, and Vietnam.

## Key facts

- **Recall number:** Z-2241-2021
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-06-23
- **Report date:** 2021-08-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Miami, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2241-2021

## Citation

> AI Analytics. FDA recall Z-2241-2021. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-2241-2021. Source: US FDA. Licensed CC0.

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