Reported Sep 5, 2018 · Terminated
Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc., Lincolnshire,…
Sysmex America, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sysmex America, Inc. · 577 Aptakisic Rd · Lincolnshire, IL · 60069-4325
Is this the product you have?
- 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.
- Lot codes and dates
9 of 9 products
Products covered by this recall # Product as published 1 A7125, exp. date 01/9/2019 2 A7126, exp. date 01/11/2019 3 A7127, exp. date 01/09/2019, A7128, exp. 01/15/2019 4 A7129, exp. 01/15/2019 5 A7130, exp. 01/17/2019 6 A7131, exp. 01/17/2019, A8003, exp. 01/31/2019 7 A8004, exp. 01/31/2019 8 A8005, exp. 02/04/2019 9 and A8006, exp. 02/04/2019. - Amount recalled
- 5,168 units
Where it was sold
- Nationwide
- PR
Why it was recalled
The fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsely low when using affected lots of Fluorocell PLT.
This product could cause temporary or reversible health problems — stop using it.
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