Novocastra Liquid Concentrated Mouse Monoclonal Antibody CD7 (LP15) Reagent; an in vitro diagnostic primary antibody for use as part of an antibody panel for the classification of tumors of T-cell origin; Catalog No. NCL-L-CD7-580; packaged in 1 mL vials and 0.1 mL vials; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. NCL-L-CD7-580 is intended for the qualitative identification by light microscopy of CD7 molecules in paraffin-embedded tissue by immunohistochemical staining.
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-1054-2012
- Quantity
- 60 - 1 mL and 11 - 0.1 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
1 mL vial, Product Code CD7-580-L-CE, lot numbers L158019 and L158020; 0.1 mL vial, Product Code CD7-580-L-CE-S, lot number L158018
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