Leica Bond Ready-to-Use Primary Antibody CD7 (LP15) Reagent; 7 mL vial; an in vitro diagnostic monoclonal antibody for use as part of an antibody panel for the classification of tumors of T-cell origin; Catalog No. PA0266; 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 CD7 molecule in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system.
This recall has been terminated (originally issued February 17, 2012).
- Company
- Leica Microsystems, Inc.
- Recall Initiated
- January 10, 2012
- Posted
- February 17, 2012
- Terminated
- April 18, 2012
- Recall Number
- Z-1053-2012
- Quantity
- 139 - 7 mL vials
- Firm Location
- Buffalo Grove, IL
- Official Source
- View on FDA website ↗
Reason for Recall
The primary antibodies to CD2 (clone 11F11) and CD7 (clone LP15) have been adulterated.
Distribution
Worldwide Distribution -- USA (nationwide) and the country of Canada.
Lot / Code Info
Catalog No. PA0266, lot numbers 10604 and 13566
Root Cause
Labeling mix-ups
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