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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 July 28, 2009
Date Posted June 25, 2010
Recall Status1 Terminated 3 on April 04, 2012
Recall Number Z-1905-2010
Recall Event ID 55495
510(K)Number K081930  
Product Classification Counter, differential cell - Product Code GKZ
Product Unicel DxH 800 Coulter Cellular Analysis System,
Part number(s): 629029
Code Information Serial Numbers: AN07020, AN05001, AN05004, AM44041, AN07015, AM51052, AN10031
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
200 S Kraemer Blvd
Brea CA 92821-6208
For Additional Information Contact B. Melina Cimler, Ph.D.
714-993-5321
Manufacturer Reason
for Recall		 The recall was initiated after Beckman Coulter confirmed an issue with the UniCel DxH 800 during in-house testing. It was determined that there is a potential for a false increase in platelet results, due to micro-bubbles. This situation could present a risk of falsely increased platelet results in patient samples as diluent containers are depleted.
FDA Determined
Cause 2		 Other
Action Beginning on July 29, 2009 Customers were contacted by Customer Technical Support (CTS) personnel and provided with the Product Corrective Action (PCA) letter. The PCA letter informed customers of the issue, the impact of the issue and actions/resolutions required by Beckman Coulter Service representative ad the affected consignee. The consignees were informed that their Beckman Coulter Service representative has made temporary changes to the Supplies setup. In addition to the Supplies setup change, consignees were instructed that one of the following workflow options must be implemented to ensure no results are affected. Please continue to follow one of the options listed below until a permanent fix is available. These options were given as: Option A: Monitor Diluent cycles or Option B: Unable to monitor Diluent cycles. The consignees were instructed that a long term solution to eliminate this risk is being developed and will be provided as soon as available. The consignees were instructed to please share this information with your laboratory staff. If they have any questions regarding this Product Corrective Action, please call 800-526-7694 in the United States or contact your local Beckman Coulter Representative.
Quantity in Commerce 7
Distribution Nationwide to: AZ, LA, IL, NY, PA & TN
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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