Sysmex America, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Sysmex America, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Serial Numbers: 1906007896 1907014703 1908002274 1908002273 1907014704 1903011967 1903011968 1903011966
Sysmex America, Inc. is recalling Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated due to Insufficient amount of antibody without an error message or alarm. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Insufficient amount of antibody without an error message or alarm
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026