Recall Z-1113-2025 ยท PER Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
Sysmex America, Inc.
Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for automated pipetting, diluting, and specimen processing workstations for flow cytometric analysis.
| Date | Feb 5, 2025 (initiated Jan 6, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| Action | A Product Notification Field Correction letter was sent to customers beginning 1/6/25. Actions: 1. Until a Sysmex representative contacts you, please do not use the instrument running PS-10 software version 1.5 or 1.6 unless it is used only to create cocktails. 2. Review the content of this communication with your facility's physician and/or pathologist and retain this letter for any future reference. 3. Please fill out the form below and email it back to Sysmex using the email address: FlowPS10@Sysmex.com Questions If you have any questions concerning this information, please contact the Te |
| Quantity | 32 units |
| Distribution | US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.