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U.S. Department of Health and Human Services

Class 2 Device Recall Leica Bond ReadytoUse Primary Antibody CD2 (11F11)

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  Class 2 Device Recall Leica Bond ReadytoUse Primary Antibody CD2 (11F11) see related information
Date Initiated by Firm January 10, 2012
Date Posted February 17, 2012
Recall Status1 Terminated 3 on April 18, 2012
Recall Number Z-1052-2012
Recall Event ID 60974
Product Classification Immunohistochemistry reagents and kits - Product Code NJT
Product 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.
Code Information Catalog No. PA0271, lot numbers 08173, 11855 and 14784
Recalling Firm/
Leica Microsystems, Inc.
1700 Leider Ln
Buffalo Grove IL 60089-6622
For Additional Information Contact Ms. M. Elizabeth Culotta
Manufacturer Reason
for Recall
The primary antibodies to CD2 (clone 11F11) and CD7 (clone LP15) have been adulterated.
FDA Determined
Cause 2
Labeling mix-ups
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
Quantity in Commerce 114 - 7 mL vials
Distribution Worldwide Distribution -- USA (nationwide) and the country of Canada.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.