Devices

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
1 Event
- Recall of Device Recall SPOTLight" HER2 CISH Kit

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

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