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U.S. Department of Health and Human Services

Enforcement Report - Week of December 19, 2012

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Product Detail

Product Description 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.
Recall Number Z-0521-2013
Classification Class II
Code Info 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
Product Distributed Qty 322 vials
Reason For Recall RTU-TdT-339 is not stable up to the expiry date on the product labeling, affecting the staining intensity.

Event Detail

Event Id 63694
Product Type Devices
Status Ongoing
Recalling Firm Leica Microsystems, Inc.
City Buffalo Grove
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-14
Initial Firm Notification of Consignee or Public Letter
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.
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