Recall Z-2497-2010
Leica Microsystems, Inc. · initiated August 2, 2010
Product
Bond Ready-To-Use Primary Antibody Thyroid Transcription Factor-1 (SPT24); 7 mL vial; an in vitro diagnostic reagent for the qualitative identification by light microscopy of human thyroid transcription factor-1 in formalin-fixed, paraffin- embedded tissue by immunohistochemical staining using the automated Bond system; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom; Catalog No.: PA0364
Codes / lots: Catalog #PA0364, lot numbers 05918, 06912, 07104, 08679, 09261, 10480, 10903
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: Device Design
Action taken
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.
Details
- Recall number
- Z-2497-2010
- Initiated
- August 2, 2010
- Posted by FDA
- September 25, 2010
- Terminated
- January 29, 2012
- Product code
- NJT – Immunohistochemistry Reagents And Kits
- Quantity
- 860 units Total for all three products
- Distribution
- Nationwide and Canada
- Recalling firm
- Leica Microsystems, Inc., Bannockburn, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2498-2010 | Lyophilized Mouse Monoclonal Antibody Thyroid Transcription Factor-1; 0.1 mL and 1 mL…In combination with a sensitive polymer detection system, the TTF-1 antibodies may stain additional tumor… | 08/02/2010Terminated |
| Z-2499-2010 | Liquid Mouse Monoclonal Antibody Thyroid Transcription Factor-1; 1 mL liquid tissue…In combination with a sensitive polymer detection system, the TTF-1 antibodies may stain additional tumor… | 08/02/2010Terminated |