Home / Recalls / Sysmex America, Inc. / Z-2687-2020

Z-2687-2020 Class II Terminated

Recalled by Sysmex America, Inc. — Lincolnshire, IL

Recall Details

Product Type
Devices
Report Date
July 29, 2020
Initiation Date
July 6, 2020
Termination Date
May 21, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8 units

Product Description

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.

Reason for Recall

Insufficient amount of antibody without an error message or alarm

Distribution Pattern

US Nationwide distribution including in the states of AL, AZ, MD, WA, FL, IL.

Code Information

Serial Numbers: 1906007896 1907014703 1908002274 1908002273 1907014704 1903011967 1903011968 1903011966

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-1113-2025 Class II — Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catal (January 6, 2025)
  • 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)