Events

Recall of K 520411-2, Hercep Test, 35Test, HER2, Protein

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Dakocytomation California 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
    33707
  • Event Risk Class
    Class 2
  • Event Number
    Z-0113-06
  • Event Date Posted
    2005-11-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-01-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42307
  • 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
    Formulation error in the visualization reagent (vial 3) component contained in hercep test kits. the error was in the concentration of polyethylene glycol contained in the formulation.
  • Action
    Notification letter dated Sept 29,2005 was sent by certified mail to consignees instructing disposal of product.

Device

K 520411-2, Hercep Test, 35Test, HER2, Protein

Manufacturer

Dakocytomation California Inc
  • Manufacturer Address
    Dakocytomation California Inc, 6392 Via Real, Carpinteria CA 93013-2921
  • Source
    USFDA