Fast-breaking News from AABB PulsePoints The following has been reproduced from the November 23, 2005 AABB PulsePoints, an electronic news alert provided by the American Association of Blood Banks.

Nov. 23, 2005
No. 722

Recall of LCG2 Leukoreduction System for Red Blood Cells

AABB PulsePoints

The Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER), on Nov. 22, 2005, announced a recall of MacoPharma Leucolab LCG2 Leukoreduction System for Red Blood Cells, lot numbers 232305F14 and 232305F20, manufactured by MacoProductions S.A.S., located in France, and distributed by UnitedPharma, located in Duluth, Ga.

According to the November 22 recall notice, "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."

DATE RECALL INITIATED:

Nov. 18, 2005

PRODUCT: MacoPharma Leucolab LCG2 Leukoreduction System for Red Blood Cells

LOT NUMBER / EXPIRATION DATE:

To view CBER’s recall notice, visit: http://www.fda.gov/cber/recalls/maclrrbc111805.htm.

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