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U.S. Department of Health and Human Services

Class 2 Device Recall UniCel DxH 800 Coulter Cellular Analysis System

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  Class 2 Device Recall UniCel DxH 800 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-0236-2018
Recall Event ID 78611
510(K)Number K140911  
Product Classification Counter, differential cell - Product Code GKZ
Product UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer
Code Information Serial Numbers:  B24802: AW10161, AW10154, AZ34449, AZ34447 629029: AT40563, AT06096, AT06095, AT02044, AW05080, AW05072, AW05066, AT50679, AS49422, AS36312, AS23151
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 15 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.
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