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U.S. Department of Health and Human Services

Class 2 Device Recall SPOTLight" HER2 CISH Kit

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  Class 2 Device Recall SPOTLight" HER2 CISH Kit see related information
Date Initiated by Firm November 14, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on February 10, 2012
Recall Number Z-0461-2012
Recall Event ID 60542
PMA Number P050040 
Product Classification Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer - Product Code NYQ
Product 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.
Code Information Lot 1029335, Exp. August 31, 2012
Recalling Firm/
Life Technologies Corporation
7305 Executive Way
Frederick MD 21704-8354
For Additional Information Contact Michael Grossman
Manufacturer Reason
for Recall
In vitro diagnostic reagent may be contaminated with a fungal contaminant.
FDA Determined
Cause 2
Material/Component Contamination
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.
Quantity in Commerce 29 kits
Distribution Worldwide Distribution - USA (nationwide) in the states of CA and NV and the countries of: Canada, Venezuela, and the UK.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = NYQ and Original Applicant = INVITROGEN CORPORATION