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Vaccines, Blood & Biologics

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Recall of LCG2 Leukoreduction System for Red Blood Cells-MacoProductions S.A.S.

DATE RECALL INITIATED:
November 18, 2005
PRODUCT / LOT NUMBERS / EXPIRATION DATE:
MacoPharma Leucolab LCG2 Leukoreduction System for Red Blood Cells
KSV0004XD
Lot Numbers: 232305F14,   232305F20
Expiration Date: June, 2008
MANUFACTURER:
MacoProductions S.A.S.
France
DISTRIBUTOR:
UnitedPharma
Duluth, Georgia
REASON:
Two lots of MacoPharma’s Leucolab LCG2 Leukoreduction System for Red Blood Cells are recalled due to potential failure to meet leukoreduction requirements. These two lots have exhibited isolated examples of failure to achieve leukoreduction of < 5 x 106 when red blood cells are processed according to the manufacturer’s instructions for use. Consignees have been asked to contact the manufacturer to arrange for product return.
    
 

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