FDA-Device2025-02-12Class II
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.
Sysmex America, Inc.
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.
Sold states
US Nationwide.
Affected count
32 units
Manufactured in
577 Aptakisic Rd, Lincolnshire, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1113-2025Don't want to check this manually?
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