Z-2953-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 5, 2018
- Initiation Date
- July 27, 2018
- Termination Date
- July 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,168 units
Product Description
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 Pattern
Worldwide Distribution: US (Nationwide) including Puerto Rico; and countries of: Argentina, Brazil, Canada, Chile, Costa Rica, Ecuador, Honduras, and Nicaragua.
Code Information
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.