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U.S. Department of Health and Human Services

Class 2 Device Recall COULTER DxH Diluent

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  Class 2 Device Recall COULTER DxH Diluent see related information
Date Initiated by Firm April 13, 2015
Date Posted May 15, 2015
Recall Status1 Terminated 3 on October 01, 2015
Recall Number Z-1616-2015
Recall Event ID 71045
510(K)Number K081930  K120771  
Product Classification Diluent, blood cell - Product Code GIF
Product COULTER DxH Diluent, Catalog No. 628017, Part No. A59956.

For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells.
Code Information Lot No. 3099980 - 3512190, expiration dates: 17 April 2015 - 26 August 2016.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer Reason
for Recall		 Beckman Coulter has received an increased number of complaints related to Hemoglobin (HGB) on UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems. The use of the DxH Diluent lots listed in the recall notice may eventually result in a compromised HGB chamber.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action An Urgent Medical Device Recall letter dated 4/13/15 was sent to customers who purchased the Coulter DxH Diluent. The letter informs customers that Beckman Coulter has received an increased number of complaints related to Hemoglobin (HGB) on UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems. The letter informs customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Customer Support Center via http://www.beckmancoulter.com/customersupport/support or call (800) 526-7694 in the US and Canada. Customers outside the US and Canada are instructed to contact their local Beckman Coulter Representative.
Quantity in Commerce 829,888 units total (659,584 units in US)
Distribution Worldwide Distribution -- Argentina; Brazil; Brunei Darussalam; Canada; Chile; Colombia; Hong Kong; India; Lebanon; Macao; Mexico; Panama; Philippines; Qatar; Singapore; Taiwan; Thailand; Trinidad and Tobago; United States, including Puerto Rico; and Uruguay.
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 = GIF and Original Applicant = BECKMAN COULTER, INC.
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