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U.S. Department of Health and Human Services

Class 3 Device Recall Leica Bond ReadytoUse Primary Antibody Epithelial Membrane Antigen (GP1.4)

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  Class 3 Device Recall Leica Bond ReadytoUse Primary Antibody Epithelial Membrane Antigen (GP1.4) see related information
Date Initiated by Firm July 26, 2011
Date Posted September 09, 2011
Recall Status1 Terminated 3 on September 09, 2011
Recall Number Z-3182-2011
Recall Event ID 59677
Product Classification Immunohistochemistry reagents and kits - Product Code NJT
Product Leica Bond Ready-to-Use Primary Antibody Epithelial Membrane Antigen (GP1.4); an in vitro diagnostic immunohistochemistry primary antibody kit; Catalog No. PA0035; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom.

Epithelial Membrane Antigen (GP1.4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human epithelial membrane antigen in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond-max system. The clinical interpretation of any staining or its absence should be complemented by morphological studies and 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 number PA0035, lot number 13622
Recalling Firm/
Manufacturer		 Leica Microsystems, Inc.
1700 Leider Ln
Buffalo Grove IL 60089-6622
For Additional Information Contact Ms. M. Elizabeth Culotta
847-405-6565
Manufacturer Reason
for Recall		 There was an issue with the controlled temperature storage unit where the products were stored prior to shipment to the customers.
FDA Determined
Cause 2		 Employee error
Action Leica Microsystems, Inc. notified all affected customers by telephone on July 26, 2011. The product, problem, and actions to be taken by the customers were discussed. Customers were instructed to discontinue use of the product and to return the product. All affected product has been returned to the firm.
Quantity in Commerce 3 units
Distribution Nationwide Distribution-in the states of Indiana and Kentucky.
Total Product Life Cycle TPLC 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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