BD EpiCenter™ Data Management System 440981Recalls & reported problems
Becton, Dickinson And Company · BD EpiCenter™ Data Management System · Class 1
All models of BD EpiCenter Data Management System (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- 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, 1 still open.
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
- Oct 31, 2024Open, Classified
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
Z-0586-2025 · Root cause: Software design · 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.
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