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U.S. Department of Health and Human Services

Class 2 Device Recall COULTER ISOTON 4 Diluent

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  Class 2 Device Recall COULTER ISOTON 4 Diluent see related information
Date Initiated by Firm July 22, 2015
Date Posted August 28, 2015
Recall Status1 Terminated 3 on December 18, 2015
Recall Number Z-2481-2015
Recall Event ID 71835
510(K)Number K011342  K061616  
Product Classification Diluent, blood cell - Product Code GIF
Product COULTER ISOTON 4 Diluent, Catalog No. 8547148. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types, such as red blood cells and platelets.
Code Information Lot Numbers: 18203F-18206F.    
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Rula Melconian
714-961-4295
Manufacturer Reason
for Recall		 Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the diluent lots may eventually result in a compromised Hgb cuvette.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action An Urgent Medical Device Recall letter dated 7/22/15 was sent to the affected customers to inform them of the issue and actions to take. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions are instructed to contact Beckman Coulter's Customer Support Center, http://www.beckmancoulter.com/customersupport/support, (800) 526-7694 in US and Canada. Customers outside of the US and Canada, are instructed to contact their local Beckman Coulter Representative.
Quantity in Commerce 710 units
Distribution Distributed US (nationwide) including Puerto Rico and U.S. Virgin Islands and the countries of Bermuda, Canada, Guatemala, Hong Kong, Mexico, Panama, Taiwan, and Trinidad-Tobago.
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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