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U.S. Department of Health and Human Services

Class 2 Device Recall Novocastra ReadytoUse Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase

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 Class 2 Device Recall Novocastra ReadytoUse Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferasesee related information
Date Initiated by FirmNovember 14, 2012
Date PostedDecember 13, 2012
Recall Status1 Terminated 3 on November 29, 2017
Recall NumberZ-0521-2013
Recall Event ID 63694
Product Classification Immunohistochemistry reagents and kits - Product Code NJT
ProductNovocastra 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.
Code Information 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
Recalling Firm/
Manufacturer		 Leica Microsystems, Inc.
1700 Leider Ln
Buffalo Grove IL 60089-6622
For Additional Information Contact
847-405-6565
Manufacturer Reason
for Recall		RTU-TdT-339 is not stable up to the expiry date on the product labeling, affecting the staining intensity.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionLeica 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 Commerce322 vials
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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