Kaluza C 5 User Network Educational LicenseRecalls & reported problems
Beckman Coulter, Inc. · Kaluza C 5 User Network Educational License · Class 1
All models of Kaluza C (9)
Data updated Oct 18, 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 18, 2026.
Recalls naming this device
- Sep 17, 2018Class IITerminated
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 LicenseBeckman Coulter, Inc. · 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
- BD EpiCenter™ Data Management System 440981Becton, Dickinson And Company · 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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