medical Class II Updated 2018-09-05

Sysmex America, Inc. recalls Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distri

Recalled Product

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.

Hazard / Issue

The fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsely low when using affected lots of Fluorocell PLT.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Reagent lot numbers: A7125, exp. date 01/9/2019; A7126, exp. date 01/11/2019; A7127, exp. date 01/09/2019, A7128, exp. 01/15/2019; A7129, exp. 01/15/2019; A7130, exp. 01/17/2019; A7131, exp. 01/17/2019, A8003, exp. 01/31/2019; A8004, exp. 01/31/2019; A8005, exp. 02/04/2019; and A8006, exp. 02/04/2019.

View official government recall

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