Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 600 Coulter Cellular Analysis System

  • 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 600 Coulter Cellular Analysis System 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-0237-2018
Recall Event ID 78611
510(K)Number K140911  
Product Classification Counter, differential cell - Product Code GKZ
Product UniCel DxH600, Part Number B23858, automated hematology analyzer

(Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand, and no connectivity capabilities)
Code Information Serial Number AZ06682  
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 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 1 unit
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.
-
-