Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
Sysmex America, Inc.'s record for this product code
MDR events0All time
Recalls2All time
510(k) clearances0All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for Sysmex America, Inc. under this product code.
Recalls
2 recall events for this product code
- Open, ClassifiedFeb 5, 2025
Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the PS-10 Sample Preparation System.
View FDA record ↗ - TerminatedUnknown
Insufficient amount of antibody without an error message or alarm
View FDA record ↗
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for Sysmex America, Inc. under this product code.