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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 Systemsee related information
Date Initiated by FirmNovember 03, 2017
Create DateDecember 13, 2017
Recall Status1 Terminated 3 on June 19, 2018
Recall NumberZ-0236-2018
Recall Event ID 78611
510(K)NumberK140911 
Product Classification Counter, differential cell - Product Code GKZ
ProductUniCel 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
ActionThe 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 Commerce15 units
DistributionCA, AR, HI, CA, OH, WA, MD, Canada, Japan
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GKZ
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