FDA Recall Terminated

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.

Recall: Z-1052-2012 · Initiated January 10, 2012

Recall

Recall Number: Z-1052-2012
Event Number: 60974
Firm: Leica Microsystems, Inc.
FEI Number: 3000210133
Product Code: NJT
Status: Terminated
Root Cause: Labeling mix-ups
Initiated: January 10, 2012
Posted: February 17, 2012
Terminated: April 18, 2012
Address: 1700 Leider Ln, Buffalo Grove, IL, 60089-6622

Description

Reason

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

Action

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

Distribution

Worldwide Distribution -- USA (nationwide) and the country of Canada.

Quantity

114 - 7 mL vials