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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 InSitesee related information
Date Initiated by FirmFebruary 09, 2006
Date PostedMarch 15, 2006
Recall Status1 Terminated 3 on August 23, 2006
Recall NumberZ-0606-06
Recall Event ID 34586
PMA NumberP040030 
Product Classification System, Test, Her-2/Neu, Ihc - Product Code MVC
ProductTest kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu IHC Kit, Manual; Model Numbers: RD134-60K; Lot Numbers: RD1340205, RD1340205X, RD1340205Y
Code Information Lot Numbers: RD1340205, RD1340205X, RD1340205Y  
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
ActionOn 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 Commerce14 units
DistributionNationwide. 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 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.
PMA DatabasePMAs with Product Code = MVC
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