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Terminated

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.

FDA Recall Z-0521-2013 · Posted 2012-12-13

Recalling FirmLeica Microsystems, Inc.
Recall StatusTerminated
Product CodeNJT
Date Initiated2012-11-14
Date Terminated2017-11-29
Product Quantity322 vials

Reason for Recall

RTU-TdT-339 is not stable up to the expiry date on the product labeling, affecting the staining intensity.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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