Events

Recall of Device Recall SPOTLight" HER2 CISH Kit

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

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
    60542
  • Event Risk Class
    Class 2
  • Event Number
    Z-0461-2012
  • Event Initiated Date
    2011-11-14
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105719
  • 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
    Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer - Product Code NYQ
  • Reason
    In vitro diagnostic reagent may be contaminated with a fungal contaminant.
  • Action
    Life Technologies sent an URGENT DEVICE RECALL letter dated November 14, 2011 by mail to all affected customers. The letter identified the product, description of problem, and actions to be taken by the user. Customers were instructed to examine inventory immediately, discontinue use, quarantine the material and return remaining inventory. Customers were advised to complete the Customer Response Sheet included for recovering inventory data and fax back to (+1) 716-774-6727 Technical Support or e-mail to techsupport@lifetech.com. Customers who had distributed the affected kits outside of their facility were instructed to immediately notify their customers of the recall. For questions call Technical Support, at (+1) 800-955-6288 opt. 2 then opt. 3.

Device

Device Recall SPOTLight" HER2 CISH Kit
  • Model / Serial
    Lot 1029335, Exp. August 31, 2012
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) in the states of CA and NV and the countries of: Canada, Venezuela, and the UK.
  • Product Description
    SPOT-Light" HER2 CISH¿ Kit, catalog #84-0150, 20 tests/kit, labeled in part ***Invitrogen Corporation 7335 Executive Way Frederick MD 21704 www.invitrogen.com*** || Product Usage: The SPOT-Light HER2 CISH Kit is intended to quantitatively determine HER2 gene amplification in formalin-fixed, paraffin-embedded (FFPE) breast carcinoma tissue sections and is indicated as an aid in the assessment of patients for whom Herceptin¿ (trastuzumab) treatment is being considered.
  • Manufacturer
    Life Technologies Corporation

Manufacturer

Life Technologies Corporation
  • Manufacturer Address
    Life Technologies Corporation, 7305 Executive Way, Frederick MD 21704-8354
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA