REMISOL Advance 2.4Recalls & reported problems
Beckman Coulter, Inc. · REMISOL Advance · Class 1
Data updated Oct 13, 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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Apr 29, 2026Open, Classified
Due to software issues where does not handle combo assay results. The software may replace the final combo test result with one of the sub-results resulting in incorrect reporting of test outcomes.
Z-2834-2026 · Root cause: Under Investigation by firm · FDA record ↗
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- 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
- BD EpiCenter™ Data Management System 440981Becton, Dickinson And Company · Calculator/data processing module, for clinical use1 recall0 reports
- Kaluza C Flow Cytometry SoftwareBeckman 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
- Kaluza C 10 User Network Educational 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 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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