Recall Z-2953-2018 ยท KQC Stains, Hematology
Sysmex America, Inc.
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.
| Date | Jul 27, 2018 |
| Status | Terminated |
| Reason | The fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsely low when using affected lots of Fluorocell PLT. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Sysmex, issued a "Product Notifications" letter dated 7/2018 via U.S. mail on 7/27/2018 to the consignees who received the affected lots. The letter was also issued to all other XN-Series customers with registered email addresses with the Sysmex Customer Resource Center via email blast on 7/27/2018 who did not directly receive the affected lots but could have received them through other channels. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1. follow your internal procedures for evaluation of flagged results. 2 |
| Quantity | 5,168 units |
| Distribution | Worldwide Distribution: US (Nationwide) including Puerto Rico; and countries of: Argentina, Brazil, Canada, Chile, Costa Rica, Ecuador, Honduras, and Nicaragua. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.