Class 2 Device Recall Beckman Coulter Slidemaker Stainer

• Date Initiated by Firm: June 20, 2017
• Create Date: September 01, 2017
• Recall Status: Terminated on April 21, 2021
• Recall Number: Z-3101-2017
• Recall Event ID: 77778
• 510(K)Number: K140911
• Product Classification: Counter, differential cell - Product Code GKZ
• Product: UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for transfer to the Stainer portion by a robot arm. Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient. A stained blood film: Allows for the differentiation of white blood cells, facilitates the characterization of red blood cells and platelets, and aids in the identification of blood components and cellular abnormalities.
• Code Information: P/N A85371AA20; Catalog No. 775222
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 250 S Kraemer Blvd; Brea CA 92821-6232
• For Additional Information Contact: Customer Service; 800-526-7694
• Manufacturer Reason for Recall: The firm has identified that a fitting in some Slidemaker Stainer units may not completely seal after installation.
• FDA Determined Cause: Employee error
• Action: Beckman Coulter sent an Urgent Medical Device Recall letter dated June 20, 2017. The notification advised consignees to immediately contact a Beckman Coulter representative if a leak is observed to schedule a service, to inspect reagent supply drawer for spills, and to follow best laboratory practices when using the device (including Personal Protective Equipment). Beckman Coulter indicates that the issue will be resolved with the replacement of the correct fitting on all impacted instruments. Labs were advised to notify all staff of the recall and to retain the notification. They were also instructed to forward the recall notice to all customers, if any product was further distributed, and to complete and return the Customer Response form within ten days of receiving the recall notification. Completed forms are to be sent back to the firm via email to Regulatory.Notifications@beckmancoulter.com. Regulatory Affairs Mail Code 31-B06. Questions can be directed to beckmancoulter.com or 800-526-7694. Consignees outside of the US are advised to contact their Beckman Coulter representative in the case that questions do arise.
• Quantity in Commerce: 310 units
• Distribution: Worldwide Distribution - USA (nationwide) Distribution to the states of : AL, AR, AZ, CA, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, VA, WA, and WV., and to the countries of : Australia, Brazil, Canada, Chile, China, Czech Republic, Denmark, France, Greece, Hong Kong, India, Israel, Italy, Japan, Morocco, Portugal, South Korea, South Africa, Spain, Taiwan, Turkey, United Kingdom, Vietnam, and Switzerland.
• 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.

• 510(K) Database: 510(K)s with Product Code = GKZ