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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 December 08, 2009
Date Posted May 26, 2010
Recall Status1 Terminated 3 on June 04, 2012
Recall Number Z-1680-2010
Recall Event ID 55462
510(K)Number K081930  
Product Classification Counter, differential cell - Product Code GKZ
Product UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029. Beckman Coulter, Inc. Brea, CA.

Quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.
Code Information All Serial Numbers
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
200 S Kraemer Blvd
Brea CA 92821-6208
Manufacturer Reason
for Recall		 The Corrective Action was initiated after Beckman Coulter confirmed three issues related to host transmissions with the UniCel DxH 800. This information only affects instruments interfaced to a host system.
FDA Determined
Cause 2		 Software design
Action Beckman Coulter, Inc. issued an "Urgent: Product Corrective Action" notification dated December 8, 2009. Consignees were informed of the affected product and provided temporary solutions until further support will be made available. For additional information, contact your local Beckman Coulter Representative or call 800-526-7694.
Quantity in Commerce 42 units (40 in US)
Distribution Distributed Nationwide and Canada.
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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