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U.S. Department of Health and Human Services

Class 2 Device Recall Beckman Coulter DxH Diluent

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  Class 2 Device Recall Beckman Coulter DxH Diluent see related information
Date Initiated by Firm August 25, 2014
Date Posted September 16, 2014
Recall Status1 Terminated 3 on February 25, 2015
Recall Number Z-2651-2014
Recall Event ID 69112
Product Classification Diluent, blood cell - Product Code GIF
Product Coulter DxH Diluent, Catalog No. 628017

Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as a diluent. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types and the measurement of hemoglobin.
Code Information Lot No. 3510470, 3510480, 3510490, 3510500, 3510510, 3510520, 3510530, 3510540, 3510550, 3510570, 3510580, 3510590, 3510600, 3510610, 3510620, 3510630, 3510690.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer Reason
for Recall		 Beckman Coulter is recalling Coulter DxH Diluent because it may be associated with elevated platelet (PLT) background counts between 3-7 x 10(3) cells/uL. This will result in failed Daily Checks on the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems.
FDA Determined
Cause 2		 Under Investigation by firm
Action Beckman Coulter sent an Urgent Medical Device Recall letter dated August 25, 2014, to all customers that purchased the Coulter DxH Diluent. The letter informed the customers of the problems identified and the actions to be taken. Customers were instructed to complete and return the enclosed response form within 10 days. Customers with questions were instructed to contact Beckman Coulter's Customer Support Center at http://www.beckmancoulter.com, or call (800) 526-7694 in the US and Canada.
Quantity in Commerce 46,050 units total (40,078 units in US)
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Canada, Chile, Mexico, Panama, and Thailand. .
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.
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