Kaluza CRecalls & reported problems across all models
Beckman Coulter, Inc. · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 9 models of Kaluza C by Beckman Coulter, Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Kaluza C recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 9 of these models · Recall details · FDA record ↗
Kaluza C models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Kaluza C Perpetual LicenseCalculator/Data Processing Module, For Clinical Use1 recall0 reports
- Kaluza C Single Use 1 Year LicenseCalculator/Data Processing Module, For Clinical Use1 recall0 reports
- Kaluza C 10 User NetworkCalculator/Data Processing Module, For Clinical Use1 recall0 reports
- Kaluza C 5 User NetworkCalculator/Data Processing Module, For Clinical Use1 recall0 reports
- Kaluza C Perpetual Education LicenseCalculator/Data Processing Module, For Clinical Use1 recall0 reports
- Kaluza C Single User 1 Year Educational LicenseCalculator/Data Processing Module, For Clinical Use1 recall0 reports
- Kaluza C 10 User Network Educational LicenseCalculator/Data Processing Module, For Clinical Use1 recall0 reports
- Kaluza C 5 User Network Educational LicenseCalculator/Data Processing Module, For Clinical Use1 recall0 reports
- Kaluza C Flow Cytometry SoftwareCalculator/Data Processing Module, For Clinical Use1 recall0 reports
Other Beckman Coulter, Inc. products
- Cytomics FC5002 models · 1,337 reports
- DxC AU4 models · 632 reports · 8 recalls
- MicroScan10 models · 7 reports · 9 recalls
- Synchron7 models · 4 reports · 5 recalls
- DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module2 models · 5 reports · 4 recalls
- UniCel DxH4 models · 74 reports · 2 recalls
- Access AccuTnI+32 models · 165 reports
- REMISOL Advance2 models · 0 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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