Device Recall SPOTLight" HER2 CISH Kit

  • Model / Serial
    Lot 1029335, Exp. August 31, 2012
  • Product Classification
  • 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
  • 1 Event

Manufacturer

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