Sysmex America, Inc. FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. Matched by name to SSMXF.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running sClass IIDec 15, 2025Under specific conditions, the lift's electromagnetic holdin	Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unint	Class IIDevices	Dec 15, 2025
Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for aClass IIJan 6, 2025Sysmex was made aware of a report of false results due to ca	Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the pr	Class IIDevices	Jan 6, 2025