FDA recall Z-2953-2018

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 for recall

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

Distribution

Worldwide Distribution: US (Nationwide) including Puerto Rico; and countries of: Argentina, Brazil, Canada, Chile, Costa Rica, Ecuador, Honduras, and Nicaragua.

Key facts

Status

Terminated

Initiation date

2018-07-27

Report date

2018-09-05

Termination date

2019-07-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lincolnshire, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2953-2018