The Recall Desk
ModerateFDA (Devices)·Z-2241-2021·Announced 2021-08-18

Kaluza C Flow Cytometry Software Recalled for Potential Erroneous Results

The FDA is recalling Kaluza C Flow Cytometry Software versions 1.0, 1.1.1, and 1.1.2 due to software anomalies that may generate erroneous results affecting diagnostic interpretation.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II precautionary recall with no reported illnesses or injuries. The hazard—software anomalies that may generate erroneous results—is theoretical and affects diagnostic accuracy rather than direct patient safety, consistent with a precautionary quality recall.

Plain-English summary

Beckman Coulter's Kaluza C Flow Cytometry Software (versions 1.0, 1.1.1, and 1.1.2) is being recalled by the FDA due to software anomalies that may generate erroneous results.

The software is used for flow cytometry analysis across multiple licensing configurations including single-user and multi-user network licenses. Approximately 1,085 units were distributed worldwide—482 in the United States and 603 internationally across numerous countries including Australia, Canada, China, Germany, France, United Kingdom, and many others.

Affected users should discontinue use of the affected software versions immediately. Beckman Coulter and the FDA recommend contacting the manufacturer for instructions regarding replacement versions or corrected software. The FDA classified this as a Class II recall due to the potential for software anomalies to produce inaccurate diagnostic results.

The recalled product

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 Perpet
Manufacturer
Beckman Coulter, Inc.
Category
Medical Device — Diagnostic Software
Hazard
  • erroneous-results
  • software-anomaly

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Versions: 1.0
  • 1.1.1 and 1.1.2

Distribution

Distributed nationwide across the United States.

Related recalls

Same category