Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Kaluza C Flow Cytometry Software Versions: 1.0* Recalled by Beckman Coulter, Inc. Due to Software anomalies that may lead to the generation...

Date: June 23, 2021
Company: Beckman Coulter, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Beckman Coulter, Inc. directly.

Affected Products

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

Quantity: 1,085 (482 US & 603 OUS)

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Beckman Coulter, Inc.

Beckman Coulter, Inc. has 79 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report