Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
Beckman Coulter, Inc.'s record for this product code
Recent MDR events
1 adverse event reports on file
Recalls
4 recall events for this product code
- Open, ClassifiedFeb 2, 2026
Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid line, result in sample loss, spillage, make instrument inoperable and will lead to unintentional removal of 60-100 microliters from final sample, may lead to incorrect diagnosis or patient management.
View FDA record ↗ - Open, ClassifiedOct 30, 2025
Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters, and E/1300/2093 microliters. Device software does not rock Cassette E, used with 15mmX92mm Sarstedt tubes. May lead to incorrect diagnosis or error in patient management/treatment.
View FDA record ↗ - TerminatedUnknown
When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow cytometer, there is an imprecision in the absolute counts on only the first tube in a run.
View FDA record ↗ - TerminatedUnknown
When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow cytometer, there is an imprecision in the absolute counts on only the first tube in a run.
View FDA record ↗
510(k) clearances
1 clearances for this product code