FDA Device recall Z-2953-2018

Sysmex XN-Series Fluorocell PLT, Catalog #CD994563

FDA Device
Class II
terminated
Published 2018-09-05

On 2018-09-05 the FDA classified a Class II recall of Sysmex XN-Series Fluorocell PLT, Catalog #CD994563 by Sysmex America, citing the fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsely low when using affected lots of Fluorocell PLT.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2953-2018
Classification	Class II
Status	terminated
Initiated	2018-07-27
Published	2018-09-05
Last updated	2026-09-13 11:54 UTC
Company	Sysmex America
Distribution	US

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.

Reason

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

Identifiers

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.… 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.

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.…

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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2953-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.