Vaccines, Blood & Biologics

Urgent Product Correction: Flow-Set Fluorosphereses

DATE CORRECTION INITIATED:

April 26, 2011

PRODUCT:

Product
Product NamePart NumberLot NumberExpiration Date
Flow-Set Fluorosphereses66070077524013F05-09-2012

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.

Page Last Updated: 08/21/2014
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