Leica Bond Ready-to-Use Primary Antibody CD2 (11F11); 7 mL vial; an in vitro diagnostic primary antibody for use as part

FDA device recall Z-1052-2012 · posted 2012-02-17 · Terminated

Recall details

Recalling firm

Leica Microsystems, Inc.

Reason for recall

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

Action taken

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

Root cause

Labeling mix-ups

Status

Terminated

Product code

NJT

Quantity affected

114 - 7 mL vials

Distribution

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

Date initiated

2012-01-10

Date posted

2012-02-17

Date terminated

2012-04-18

Location

Buffalo Grove, IL