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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Urgent Product Correction: Flow-Set Fluorosphereses

DATE CORRECTION INITIATED:
 
April 26, 2011
 
PRODUCT:
 

Product NamePart  NumberLot NumberExpiration Date
 
Flow-Set Fluorosphereses
 
6607007
 
 
       7524013F
 
 
05-09-2012

MANUFACTURER:
 
Beckman Coulter, Inc.
Miami, Florida
 
REASON:
 
Beckman Coulter has confirmed an issue with the Flow-Set Fluorospheres.   The Table of Application Target Settings has some incorrect Target Values for stemONE and stemCXP.  Customers are asked to follow the instruction on the Flow Set insert in editing stemOne and stemCXP protocols on their XL or FC500 Software with the correct target value. 

The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.