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U.S. Department of Health and Human Services

Class 2 Device Recall InSite

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  Class 2 Device Recall InSite see related information
Date Initiated by Firm February 09, 2006
Date Posted March 15, 2006
Recall Status1 Terminated 3 on August 23, 2006
Recall Number Z-0608-06
Recall Event ID 34586
PMA Number P040030 
Product Classification System, Test, Her-2/Neu, Ihc - Product Code MVC
Product Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu Monoclonal Antibody, Manual;
Model number: AM134-5MP;
Lot Numbers: AM134P1005
Code Information Lot Numbers: AM134P1005 
Recalling Firm/
Manufacturer		 Biogenex Laboratories
4600 Norris Canyon Rd
San Ramon CA 94583-1320
Manufacturer Reason
for Recall		 Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result.
FDA Determined
Cause 2		 Other
Action On 2/9/06, the firm issued letters via UPS to all of its consignees, informing them of the affected products and providing instructions on the recall.
Quantity in Commerce 1 unit
Distribution Nationwide. Italy, and United Kingdom. The product was released for distribution to 21 consignees nationwide to CA, FL, GA, IA, IL, NC, NJ, NY, TX, VT, WA, and WI. One VA account: VA Medical Center, Gwen Levy, Bld. 500, Room 1238, 11301 Wilshire Blvd., Los Angeles, CA 90073. 2 overseas consignees distributed the product to Italy (Space Imports Export SPL, Via Ranzato, 12, 1-20128 Milano, Italy and United Kingdom (Launch Diagnosis, West Yoke Farm unit 11, Michaels, Lane, Sevenoaks, Kent, TN15 7EP United Kingdom
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.
PMA Database PMAs with Product Code = MVC and Original Applicant = BIOGENEX LABORATORIES, INC.
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