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.
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: 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…
- Manufacturer
- Beckman Coulter Inc.
- Category
- Medical Device — Software
- Affected units
- 41
Distribution
Related recalls
Same manufacturer · Beckman Coulter Inc.
See all →- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- HighBeckman Coulter DxC 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- High
Same hazard · software compatibility
See all →- HighProstate imaging software recalled over accessories that may fail on Windows 10
FDA (Devices) · 2026-02-11
- ModerateUltrasound systems recalled over compatibility failures with Apple devices running iOS 18
FDA (Devices) · 2025-12-10
- ModerateMedtronic StealthStation Software Recalled Due to Scanner Compatibility Issues
FDA (Devices) · 2016-08-10
Similar recalls
- ModerateKaluza C Flow Cytometry Software Recalled for Potential Erroneous Results
FDA (Devices) · 2021-08-18
- ModerateBeckman Coulter Recalls DxC 600/800 Analyzers Due to Software Alignment Issue
FDA (Devices) · 2012-10-31
- HighBeckman Coulter DxI 9000 Access analyzer software causes delayed test results
FDA (Devices) · 2024-08-21
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighClinical Chemistry Analyzer Recalled for Software Defect in Test Result Calculation
FDA (Devices) · 2025-04-09
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14