Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that

FDA device recall Z-2651-2014 · posted 2014-09-16 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

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.

Action taken

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

Status

Terminated

Product code

GIF

Quantity affected

46,050 units total (40,078 units in US)

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to Canada, Chile, Mexico, Panama, and Thailand. .

Date initiated

2014-08-25

Date posted

2014-09-16

Date terminated

2015-02-25

Location

Brea, CA