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Sysmex America, Inc. recalls Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for a
Recalled February 12, 2025 · FDA recall Z-1113-2025 · Sysmex America
Hazard
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 Class II
Units
32 units
Sold at
US Nationwide.
Description
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.
Product
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.
Manufacturer(s)
Sysmex America, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →