Kaluza C 10 User NetworkRecalls & reported problems
Beckman Coulter, Inc. · Kaluza C 10 User Network · Class 1
All models of Kaluza C (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗
Other Calculator/Data Processing Module, For Clinical Use devices
- BD Synapsys™ Informatics Solution 444150Becton, Dickinson And Company · Calculator/data processing module, for clinical use5 recalls81 reports
- cobas® infinity central lab 07154003001Roche Diagnostics GmbH · Calculator/data processing module, for clinical use2 recalls31 reports
- BD EpiCenter™ Data Management System 441007Becton, Dickinson And Company · CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE1 recall21 reports
- Expanse Laboratory/Genetics/Microbiology/Anatomical PathologyMedical Information Technology, Inc. · Calculator/Data Processing Module, For Clinical Use1 recall2 reports
- Kaluza C Perpetual Education LicenseBeckman Coulter, Inc. · Calculator/Data Processing Module, For Clinical Use1 recall0 reports
- Kaluza C Single Use 1 Year LicenseBeckman Coulter, Inc. · Calculator/Data Processing Module, For Clinical Use1 recall0 reports
- TDHisto/CytoTechnidata · Calculator/Data Processing Module, For Clinical Use1 recall0 reports
- Kaluza C Perpetual LicenseBeckman Coulter, Inc. · Calculator/Data Processing Module, For Clinical Use1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page