Leica Bond Ready-to-Use Primary Antibody CD2 (11F11); 7 mL vial; an in vitro diagnostic primary antibody for use as part of an antibody panel for the characterization of T cell disorders; Catalog No. PA0271; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. For the qualitative identification by light microscopy of human CD2 molecule in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system.

The primary antibodies to CD2 (clone 11F11) and CD7 (clone LP15) have been adulterated.

Leica Microsystems, Inc. sent a Medical Device Field Notification letter dated January 4, 2012, via first class mail on January 10, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to discontinue use of the product and to return the product to the firm. Customers who have received the affected lot numbers of the listed products were requested to return any unused/part used reagents to the Buffalo Grove, IL, location for replacement. The accounts were asked to complete the attached Acknowledgement Form, acknowledging receipt and understanding of the letter, listing the lot numbers of the units at their facility and fax it back to Leica at 1-847-607-3147. Additional questions should be addressed to the account's Leica Representative. For further questions please call (847) 405-0123