# FDA recall Z-1982-2019

> **Beckman Coulter Inc.** · Class II · device recall initiated 2018-09-17.

## Product

Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following  software devices:    (A) Kaluza C Perpetual License  (B) Kaluza C Single Use 1 Year License  (C) Kaluza C 5 User Network  (D) Kaluza C 10 User Network  (E) Kaluza C Perpetual Educational License  (F) Kaluza C Single User 1 Year educational License  (G) Kaluza C 10 User Network Educational License  (H) Kaluza C 5 User Network Educational License  (I) Kaluza C Flow Cytometry Software

## Reason for recall

Compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10.  The compatibility issue causes the software to be unusable  which could result in a delay of reporting results.

## Distribution

US: CA and NY  OUS: United Kingdom, Switzerland and Germany

## Key facts

- **Recall number:** Z-1982-2019
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-17
- **Report date:** 2019-07-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brea, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1982-2019

## Citation

> AI Analytics. FDA recall Z-1982-2019. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-1982-2019. Source: US FDA. Licensed CC0.

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