Bond Ready-To-Use Primary Antibody Thyroid Transcription Factor-1 (SPT24); 7 mL vial; an in vitro diagnostic reagent for

FDA device recall Z-2497-2010 · posted 2010-09-25 · Terminated

Recall details

Recalling firm

Leica Microsystems, Inc.

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.

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.

Root cause

Device Design

Status

Terminated

Product code

NJT

Quantity affected

860 units Total for all three products

Distribution

Nationwide and Canada

Date initiated

2010-08-02

Date posted

2010-09-25

Date terminated

2012-01-29

Location

Bannockburn, IL