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U.S. Department of Health and Human Services

Class 2 Device Recall Sysmex PS10 Sample Preparation System

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 Class 2 Device Recall Sysmex PS10 Sample Preparation Systemsee related information
Date Initiated by FirmJanuary 06, 2025
Date PostedFebruary 05, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1113-2025
Recall Event ID 96107
Product Classification Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis - Product Code PER
ProductSysmex 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.
Code Information UDI-DI: 04987562501908; Serial Numbers: 1908002275 1908002276 1908009775 1910009588 1910011295 1912002638 2103013913 2108004629 2108004630 2108004631 2108004632 2112005423 2112005425 2203014206 2203014207 2203014208 2205012732 2205012734 2206005973 2206012294 2208015835 2210003722 2210003723 2210003724 2212010048 1903011966 1903011968 1910009589 1912002640 2103013912 2208015834 1903011967
FEI Number 3009711478
Recalling Firm/
Manufacturer		 Sysmex America, Inc.
577 Aptakisic Rd
Lincolnshire IL 60069-4325
For Additional Information ContactTechnical Assistance Center (TAC)
888-879-7639
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Software design
ActionA 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 Technical Assistance Center at 1- 888-879-7639 An additional Product Notification Field Correction letter was sent to customers beginning 4/9/25. Software Correction The probe washing processes have been updated to incorporate essential washing steps during antibody pipetting. The PS-10 antibody pipetting washing sequence has been reinstated, ensuring a washing step is performed when switching between antibody vials. This update prevents any potential carry-over between antibody reagents. This correction addresses the potential risk of antibody carryover, as detailed in Field Correction Notice CF-08823, released in December 2024. Action 1. Please distribute this product notification as appropriate to your laboratory staff. 2. File this product notification as a part of your laboratory s quality system as required. Questions If you have questions concerning this information, please message the Sysmex Technical Assistance Center (TAC). Simply click on the support tab on the home page of the CRC, click the Create New Issue button under Help Me to send your question to TAC. Choose Technical Assistance-Equipment in the dropdown to complete the form and submit it. Sending a message to TAC is recommended for non-urgent requests. For Canadian customers, please note messages to TAC are only processed in English. For urgent requests, contact the Technical Assistance Center at 1-8
Quantity in Commerce32 units
DistributionUS Nationwide.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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