Recall Z-2953-2018— Sysmex America, Inc.
Class II · Terminated
Class II FDA medical device recall by Sysmex America, Inc., initiated 2018-07-27, terminated 2019-07-08. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Sysmex America, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-07-27
- Terminated
- 2019-07-08
- Firm location
- Lincolnshire, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.