• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall UniCel DxH Slidemaker Stainer

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall UniCel DxH Slidemaker Stainer see related information
Date Initiated by Firm November 03, 2017
Create Date December 13, 2017
Recall Status1 Terminated 3 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/
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact
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 2
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.