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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 March 02, 2010
Date Posted May 26, 2010
Recall Status1 Terminated 3 on May 23, 2012
Recall Number Z-1656-2010
Recall Event ID 55194
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
For Additional Information Contact
714-993-5321
Manufacturer Reason
for Recall		 Issue 1: The Diagnostic procedure, Simulate-CDNR Cycle, is not functioning properly. Impact: There is a potential for inadequate sample preparation of samples following the use of this Diagnostic function impacting WBC, Differential, Reticulocyte and/or NRBC results. Issue 2: Use of the Auto Prune function causes the deletion of Quality Control files. Impact: If the last run for a control lot
FDA Determined
Cause 2		 Software design
Action Beckman Coulter, Inc. issued an "Urgent: Product Corrective Action" notification dated March 10, 2010. Consignees were informed of the affected product and instructed on proper steps to take and requested to return the enclosed acknowledgement form. For further information, contact your local Beckman Coulter Representative or call 1-800-526-7694.
Quantity in Commerce 63 units
Distribution Nationwide Distribution (AZ, CA, CO, FL, GA, IA, IL, IN, KS, LA, MO, NC, NJ, NV, NY, OH, PA, SC, TN, TX, UT, WA, and WI) 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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