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U.S. Department of Health and Human Services

Class 2 Device Recall Sysmex PS10

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  Class 2 Device Recall Sysmex PS10 see related information
Date Initiated by Firm July 06, 2020
Create Date July 22, 2020
Recall Status1 Terminated 3 on May 21, 2021
Recall Number Z-2687-2020
Recall Event ID 85959
Product Classification Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis - Product Code PER
Product Sysmex PS-10 Sample Preparation System
Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable, open system intended for use to prepare human specimens for subsequent analysis on flow cytometers.
Code Information Serial Numbers: 1906007896 1907014703 1908002274 1908002273 1907014704 1903011967 1903011968 1903011966  
Recalling Firm/
Manufacturer		 Sysmex America, Inc.
577 Aptakisic Rd
Lincolnshire IL 60069-4325
For Additional Information Contact Sysmex Technical Assistance Center (TAC)
224-543-9514
Manufacturer Reason
for Recall		 Insufficient amount of antibody without an error message or alarm
FDA Determined
Cause 2		 Software design
Action Sysmex issued a field corrective action on July 6, 2020. The product notification states the following actions to be taken: 1. A Sysmex Service Engineer will be scheduled to adjust the probe height to correct the issue from occurring when using the Sysmex antibody vials. The PS-10 should not be used to perform any testing, other than internal validation, until the adjustment is completed. 2. Discontinue use of non-Sysmex antibody vials in the PS-10 for testing until Sysmex hascompleted the verification, unless your internal procedures ensure the required accuracy of the pipetted volume. 3. Please distribute this Product Notification as appropriate to your laboratory 4. File this Product Notification as a part of your laboratorys Quality System as required For urgent requests, call the Technical Assistance Center at 1-888-879- 7639 in the U.S., or at 1-888-679-7639 in Canada
Quantity in Commerce 8 units
Distribution US Nationwide distribution including in the states of AL, AZ, MD, WA, FL, IL.
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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