Recall Atlas

Sysmex recalls

2 official recalls and safety alerts involving Sysmex since 2025-02, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Sysmex or the relevant agency.

  1. 2026-01-28
  2. US
    Drugs & medicalClass II

    Sysmex America, Inc. recalls TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions…

    Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.

    FDA · DeviceSysmex America, Inc.US Nationwide.Official notice →
  3. 2025-02-12
  4. US
    Drugs & medicalClass II

    Sysmex America, Inc. recalls Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for automated pipetting,…

    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.

    FDA · DeviceSysmex America, Inc.US Nationwide.Official notice →