Home / Recalls / Sysmex America, Inc. / Z-1113-2025

Z-1113-2025 Class II Ongoing

Recalled by Sysmex America, Inc. — Lincolnshire, IL

Recall Details

Product Type
Devices
Report Date
February 12, 2025
Initiation Date
January 6, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
32 units

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.

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.

Distribution Pattern

US Nationwide.

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

Other recalls by Sysmex America, Inc.

  • Z-1136-2026 Class II — TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample t (December 15, 2025)
  • Z-2687-2020 Class II — Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: (July 6, 2020)
  • Z-1703-2020 Class II — The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives m (March 9, 2020)
  • Z-1717-2020 Class II — Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens t (January 21, 2020)
  • Z-2953-2018 Class II — Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. (July 27, 2018)
  • Z-0045-2018 Class II — Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a dilute (September 8, 2017)
  • Z-2034-2017 Class II — Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakin (March 23, 2017)
  • Z-2770-2016 Class II — Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain plate (July 1, 2016)
  • Z-0100-2014 Class II — pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lb (May 15, 2013)
  • Z-0949-2014 Class II — The UF-1000i is a fully automated urine particle analyzer intended for vitro dia (March 31, 2013)