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Field Correction - ALBAcyte Antibody Screening Cells
DATE NOTIFICATION INITIATED: April 18, 2013
PRODUCT / LOT NUMBER
ALBAcyte Antibody Screening Cells
Product Code Z451U
Lot Number V133096
Quotient Biodiagnostics Inc.
After shipment, it was discovered that there was a mistake in the antigen profile prepared and shipped with ALBAcyte Antibody Screening Cells, product code Z451U, lot number V133096, expiring on May 20, 2013. On the antigen profile, the antigen types reported for the V antigen on both Cell # 1 as well as Cell # 2 were incorrectly recorded as V+. Both Cell # 1 and Cell # 2 are, however, negative for the V antigen. A corrected antigen profile for lot V133096 was provided.
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.