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Class 2 Device Recall InSite |
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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
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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
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Code Information |
Lot Numbers: AM134P1005 |
Recalling Firm/ Manufacturer |
Biogenex Laboratories 4600 Norris Canyon Rd San Ramon CA 94583-1320
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Manufacturer Reason for Recall |
Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result.
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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
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Total Product Life Cycle |
TPLC Device Report
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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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PMA Database |
PMAs with Product Code = MVC and Original Applicant = BIOGENEX LABORATORIES, INC.
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