Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sysmex XN-Series Fluorocell PLT Recalled by Sysmex America, Inc. Due to The fluorescent platelet counts (PLT-F) and immature platelet...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sysmex America, Inc. directly.
Affected Products
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.
Quantity: 5,168 units
Why Was This Recalled?
The fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsely low when using affected lots of Fluorocell PLT.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sysmex America, Inc.
Sysmex America, Inc. has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report