Sysmex America, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1113-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 6, 2025

Date Posted: February 12, 2025

Recall Number: Z-1113-2025

Event ID: 96107

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.

Status: Ongoing

Product Quantity: 32 units

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

Distribution Pattern:

US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated