Field Action Notification
Becton Dickinson (BD) Procount Kit
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.
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.