Z-0521-2013Class II

Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent; an...

Name: Z-0521-2013 Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent; an...
Creator: Leica Microsystems, Inc.
Published: 2012-11-14
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2012-11-14 / Terminated / root cause: manufacturing process

FDA source

Leica Microsystems, Inc. began a recall of Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent; an in vitro staining reagent for the qualitative... on 2012-11-14. FDA classified it as Class II and gives the reason as "RTU-TdT-339 is not stable up to the expiry date on the product labeling, affecting the staining intensity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0521-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-14
Posted: 2012-12-13
Terminated: 2017-11-29
Recalling firm: Leica Microsystems, Inc.
Product: Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent; an in vitro staining reagent for the qualitative identification by light microscopy of Terminal Deoxynucleotidyl Transferase molecules in paraffin sections; Catalog No. RTU-TdT-339; packaged in 7 mL vials; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. RTU-TdT-339 is intended for the qualitative identification by light microscopy of Terminal Deoxynucleotidyl Transferase molecules in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
Product code: NJT Immunohistochemistry Reagents And Kits
Reason for recall: RTU-TdT-339 is not stable up to the expiry date on the product labeling, affecting the staining intensity.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Leica Microsystems, Inc. sent a Product Recall Notification letter dated November 14, 2012, via first class mail on the same date, to all affected customers. The letter identified the product ,the problem, and the actions to be taken by the customers. Customers were instructed to discontinue use of the product and to return any unused/part used reagents to the Richmond, 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 1-847-236-3747. Additional questions should be addressed to the account's Leica Representative.
Quantity in commerce: 322 vials
Distribution: Worldwide Distribution -- USA including Arkansas, California, Florida, Illinois, Maryland, Michigan, Minnesota, Missouri, North Carolina, Oregon, Rhode Island, Tennessee, Texas and Wisconsin, and the country of Canada.
Product codes and lots: Catalog No. RTU-TdT-339, lot numbers 6001845, expiry 2012-11 and 6009645, expiry 2014-04 The recall also included the folowing expired lots: 804804, 804805, 804806, 804809, 804810, 804812

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0521-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0521-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-13

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)