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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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…
- Manufacturer
- Beckman Coulter, Inc.
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
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