Class 2 Device Recall Sysmex Fluorocell PLT

• Date Initiated by Firm: July 27, 2018
• Create Date: August 30, 2018
• Recall Status: Terminated on July 08, 2019
• Recall Number: Z-2953-2018
• Recall Event ID: 80716
• Product Classification: Stains, hematology - Product Code KQC
• 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.
• 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.
• FEI Number: 3009711478
• Recalling Firm/ Manufacturer: Sysmex America, Inc.; 577 Aptakisic Rd; Lincolnshire IL 60069-4325
• For Additional Information Contact: Ms. Jasna Frontz; 224-543-9753
• Manufacturer 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.
• FDA Determined 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. Distribute this Product Notification to the appropriate personnel to take the following actions: 3. Upon receipt of unaffected lots of replacement reagent, immediately exchange any affected Fluorocell PLT cartridges currently in use on your analyzer. 4. Discard any remaining affected lots in inventory according to your laboratorys protocols and procedures. 5.Please proceed to the URL: http://pages.sysmex.com/fluorocellrecall.html to complete the Fluorocell Recall Response Form. Confirm receipt and understanding of the Product Notification. Sysmex will replace the quantity of affected lot(s) identified in this Product Notification that are confirmed to be currently in your inventory. If you have any questions concerning this information, please contact Sysmex Quality Assurance Department at quality@sysmex.com.br.
• Quantity in Commerce: 5,168 units
• Distribution: Worldwide Distribution: US (Nationwide) including Puerto Rico; and countries of: Argentina, Brazil, Canada, Chile, Costa Rica, Ecuador, Honduras, and Nicaragua.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.