Beckman Coulter Recalls Kaluza C Flow Cytometry Software Due to Compatibility Issues
Beckman Coulter is recalling Kaluza C Flow Cytometry Software because compatibility issues with Microsoft Windows updates render the software unusable, potentially delaying the reporting of results.
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: The recall is classified as FDA Class II. The hazard is a software compatibility issue causing the software to be unusable, which may delay reporting results. There are no reports of injury, illness, or death, and the risk is primarily operational rather than direct physical harm.
Plain-English summary
Beckman Coulter Inc. is recalling 41 units of Kaluza C Flow Cytometry Software, which is available by prescription only in the United States. The recall covers various license types, including perpetual, single-use, and network licenses for both commercial and educational use.
The recall is due to a compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. This issue causes the software to be unusable, which could result in a delay in reporting results. The affected units were distributed in California and New York in the United States, as well as in the United Kingdom, Switzerland, and Germany.
Users of the affected software should contact Beckman Coulter Inc. for further instructions regarding the recall. The specific product codes and UDI codes for the affected units are listed in the official recall documentation.
The recalled product
- 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 Educati
- Manufacturer
- Beckman Coulter Inc.
- Category
- Medical Device — Software
- Affected units
- 41
Distribution
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