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Vaccines, Blood & Biologics

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


August 10, 2006


Procount Progenitor Cell Enumeration Kit
Lot Number 45602
Catalog Number 340498


BD Biosciences
San Jose, California


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.

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 06/27/2013
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