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U.S. Department of Health and Human Services

Class 2 Device Recall Novocastra Thyroid Transcription Factor1 (lyophilized)

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  Class 2 Device Recall Novocastra Thyroid Transcription Factor1 (lyophilized) see related information
Date Initiated by Firm August 02, 2010
Date Posted September 25, 2010
Recall Status1 Terminated 3 on January 29, 2012
Recall Number Z-2498-2010
Recall Event ID 56406
Product Classification Immunohistochemistry Reagents And Kits - Product Code NJT
Product Lyophilized Mouse Monoclonal Antibody Thyroid Transcription Factor-1; 0.1 mL and 1 mL lyophilized tissue culture supernatant in vials; an in vitro diagnostic reagent for the qualitative identification by light microscopy of thyroid transcription factor-1 molecules in paraffin-embedded tissue by immunohistochemical staining; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom; Catalog No.: NCL-TTF-1
Code Information Catalog #NCL-TTF-1, lot numbers 136439, 136442, 136441S, 136447, 6000563 and 6004009
Recalling Firm/
Manufacturer		 Leica Microsystems, Inc.
2345 Waukegan Rd
Bannockburn IL 60015-1515
For Additional Information Contact Ms. M. Elizabeth Culotta
847-405-6565
Manufacturer Reason
for Recall		 In combination with a sensitive polymer detection system, the TTF-1 antibodies may stain additional tumor types other than is currently indicated on the instructions for use.
FDA Determined
Cause 2		 Device Design
Action Leica Microsystems sent Medical Device Field Correction letters dated 7/28/10 to the affected customers via first class mail on the same date, informing them that in combination with a sensitive polymer detection system, the TTF-1 antibodies may stain additional tumor types other than is currently indicated on the Instructions for Use. Currently they state that lung and thyroid tumors may stain, but Leicas investigation further characterized the expression of the TTF-1 antigen and it may also be present in other tumors, e.g. thymomas. Customers who have received the affected lot numbers of the three products were requested to refer to the new Instructions for Use to review the amendments made to the Results Expected via the following links: http://bsd.leica-microsystems.com/pdfs/products/ttf-1-ce.pdf; http://bsd.leica-microsystems.com/pdfs/products/ttf-1-l-ce.pdf; and http://bsd.leica-microsystems.com/pdfs/products/pa0364.pdf; The accounts were asked to complete the attached Acknowledgement Form, acknowledging the 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 firm's office of Regulatory Affairs and Quality Assurance.
Quantity in Commerce 860 units Total for all three products
Distribution Nationwide and 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.
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