Events

Recall of Device Recall InSite HER2/neu Detection Kit

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

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
    68709
  • Event Risk Class
    Class 2
  • Event Number
    Z-2113-2014
  • Event Initiated Date
    2014-07-01
  • Event Date Posted
    2014-07-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128488
  • 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
    Pathology Test System - Product Code MVC
  • Reason
    Product was distributed without 510(k) approval.
  • Action
    Each customer contacted by phone - neither is in possession of the product.

Device

Device Recall InSite HER2/neu Detection Kit
  • Model / Serial
    Catalog number RD471-60K: Lot numbers: RD4710111, Exp Jan 2012; RD4710411, Exp. Apr 2012; RD4711013, Exp Oct 2014.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Brazil and Ecuador. No US distribution
  • Product Description
    InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
  • Manufacturer
    Biogenex Laboratories, Inc.

Manufacturer

Biogenex Laboratories, Inc.
  • Manufacturer Address
    Biogenex Laboratories, Inc., 49026 Milmont Dr, Fremont CA 94538-7301
  • Source
    USFDA