Z-2498-2010

Lyophilized Mouse Monoclonal Antibody Thyroid Transcription Factor-1; 0.1 mL and 1 mL lyophilized tissue...

Name: Z-2498-2010 Lyophilized Mouse Monoclonal Antibody Thyroid Transcription Factor-1; 0.1 mL and 1 mL lyophilized tissue...
Creator: Leica Microsystems, Inc.
Published: 2010-08-02
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2010-08-02 / Terminated / root cause: design

FDA source

Leica Microsystems, Inc. began a recall of Lyophilized Mouse Monoclonal Antibody Thyroid Transcription Factor-1; 0.1 mL and 1 mL lyophilized tissue culture supernatant in vials; an in vitro diagnostic... on 2010-08-02. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2498-2010
Status: Terminated
Initiated: 2010-08-02
Posted: 2010-09-25
Terminated: 2012-01-29
Recalling firm: Leica Microsystems, Inc.
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
Product code: NJT Immunohistochemistry Reagents And Kits
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.
Root cause tag: design
FDA root cause: 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
Product codes and lots: Catalog #NCL-TTF-1, lot numbers 136439, 136442, 136441S, 136447, 6000563 and 6004009

Product code NJT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)