Events

Recall of Device Recall InSite

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biogenex Laboratories.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    34586
  • Event Risk Class
    Class 2
  • Event Number
    Z-0608-06
  • Event Initiated Date
    2006-02-09
  • Event Date Posted
    2006-03-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-08-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44143
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, Test, Her-2/Neu, Ihc - Product Code MVC
  • Reason
    Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result.
  • 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.

Device

Device Recall InSite
  • Model / Serial
    Lot Numbers: AM134P1005
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    3
  • Implanted device?
    No
  • 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
  • Product Description
    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, Automated; || Model number: AM134-10MP; || Lot Numbers: AM134P1005
  • Manufacturer
    Biogenex Laboratories

Manufacturer

Biogenex Laboratories
  • Manufacturer Address
    Biogenex Laboratories, 4600 Norris Canyon Rd, San Ramon CA 94583-1320
  • Source
    USFDA