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.
FDA Recall Z-2651-2014 · Posted 2014-09-16
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Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeGIF
Date Initiated2014-08-25
Date Terminated2015-02-25
Product Quantity46,050 units total (40,078 units in US)
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.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide Distribution - USA (nationwide) and Internationally to Canada, Chile, Mexico, Panama, and Thailand. .
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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