FDAJuly 27, 2018device
Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc., Lincolnshire, IL. Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsely low when using affected lots of Fluorocell PLT.
What to do
FDA enforcement status: Terminated
Brands named
sysmex americasysmex
Recall history
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