Brand
Sysmex America, Inc.
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Sysmex America, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-01-28FDA-DeviceClass IITS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17
Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.
- 2025-02-12FDA-DeviceClass IISysmex 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.
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.
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