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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Field Action Notification - Becton Dickinson (BD) Procount Kit-BD Biosciences

DATE NOTIFICATION INITIATED:

August 10, 2006

PRODUCT / LOT NUMBER:

Procount Progenitor Cell Enumeration Kit
Lot Number 45602
Catalog Number 340498

MANUFACTURER:

BD Biosciences
San Jose, California

REASON:

BD Biosciences requests users discontinue further use of Lot 45602 because it has been determined that the expression of CD45PerCP is outside of the specification (low). This lower expression can result in poor resolution between CD45+ and CD34+ populations therefore requiring manual gating by the user. Consignees have been asked to contact the manufacturer to arrange for product return.

 

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(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

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Food and Drug Administration

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Suite 200N/HFM-47

Rockville, MD 20852-1448