Kaluza C Flow Cytometry SoftwareRecalls & reported problems
Beckman Coulter, Inc. · Kaluza C Flow Cytometry Software · Class 1
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Sep 17, 2018Terminated
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.
Z-1982-2019 · Root cause: Software Manufacturing/Software Deployment · FDA record ↗
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- Expanse Laboratory/Genetics/Microbiology/Anatomical PathologyMedical Information Technology, Inc. · Calculator/Data Processing Module, For Clinical Use1 recall2 reports
- BD EpiCenter™ Data Management System 440981Becton, Dickinson And Company · Calculator/data processing module, for clinical use1 recall0 reports
- Kaluza C 10 User NetworkBeckman Coulter, Inc. · Calculator/Data Processing Module, For Clinical Use1 recall0 reports
- REMISOL Advance 2.4Beckman Coulter, Inc. · Calculator/Data Processing Module, For Clinical Use1 recall0 reports
- Kaluza C 10 User Network Educational LicenseBeckman Coulter, Inc. · Calculator/Data Processing Module, For Clinical Use1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.