Class 2 Device Recall UniCel DxH Slidemaker Stainer

• Date Initiated by Firm: November 03, 2017
• Create Date: December 13, 2017
• Recall Status: Terminated on June 19, 2018
• Recall Number: Z-0238-2018
• Recall Event ID: 78611
• 510(K)Number: K140911
• Product Classification: Counter, differential cell - Product Code GKZ
• Product: UniCel DxH Slidemaker Stainer, Part Number 75222, for use with automated hematology analyzer
• Code Information: Serial Numbers: AW09034, AV40142, AU19113
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 250 S Kraemer Blvd; Brea CA 92821-6232
• For Additional Information Contact: 469-961-4941
• Manufacturer Reason for Recall: The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.
• FDA Determined Cause: Device Design
• Action: The firm notified its consignees of the recall on 11/03/2017 by letter. The letter stated the issue and provided the following instructions: ¿ "To avoid a biohazardous spill, do not use the right (green) position of the Single-Tube Station for sample aspiration until the shield is removed. ¿ You may remove the shield following the instructions in Attachment 1 or contact your local Beckman Coulter Representative for further assistance."
• Quantity in Commerce: 3 units
• Distribution: CA, AR, HI, CA, OH, WA, MD, Canada, Japan
• 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 and Original Applicant = BECKMAN COULTER, INC.