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U.S. Department of Health and Human Services

Class 2 Device Recall InSite HER2/neu Detection Kit

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  Class 2 Device Recall InSite HER2/neu Detection Kit see related information
Date Initiated by Firm July 01, 2014
Date Posted July 24, 2014
Recall Status1 Terminated 3 on July 24, 2014
Recall Number Z-2113-2014
Recall Event ID 68709
Product Classification Pathology Test System - Product Code MVC
Product InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
Code Information Catalog number RD471-60K: Lot numbers: RD4710111, Exp Jan 2012; RD4710411, Exp. Apr 2012; RD4711013, Exp Oct 2014.
Recalling Firm/
Manufacturer		 Biogenex Laboratories, Inc.
49026 Milmont Dr
Fremont CA 94538-7301
For Additional Information Contact Ajoy Kumar Prem
510-824-1440
Manufacturer Reason
for Recall		 Product was distributed without 510(k) approval.
FDA Determined
Cause 2		 No Marketing Application
Action Each customer contacted by phone - neither is in possession of the product.
Quantity in Commerce 4 kits
Distribution Brazil and Ecuador. No US distribution
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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