Date Initiated by Firm | January 10, 2012 |
Date Posted | February 17, 2012 |
Recall Status1 |
Terminated 3 on April 18, 2012 |
Recall Number | Z-1054-2012 |
Recall Event ID |
60974 |
Product Classification |
Immunohistochemistry reagents and kits - Product Code NJT
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Product | 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. |
Code Information |
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 |
Recalling Firm/ Manufacturer |
Leica Microsystems, Inc. 1700 Leider Ln Buffalo Grove IL 60089-6622
|
For Additional Information Contact | Ms. M. Elizabeth Culotta 847-405-0123 |
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 | 60 - 1 mL and 11 - 0.1 mL vials |
Distribution | Worldwide Distribution -- USA (nationwide) and the country of Canada. |
Total Product Life Cycle | TPLC Device Report |
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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.
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