FDAJanuary 6, 2025device
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 recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
sysmex americasysmex
UPCs
04987562501908
Recall history
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