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.
FDA Recall Z-0461-2012 · Posted 2012-01-11
Recalling FirmLife Technologies Corporation
Recall StatusTerminated
Product CodeNYQ
Date Initiated2011-11-14
Date Terminated2012-02-10
Product Quantity29 kits
Reason for Recall
In vitro diagnostic reagent may be contaminated with a fungal contaminant.
Firm 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 [email protected]. 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.
Root Cause
Material/Component Contamination
Distribution Pattern
Worldwide Distribution - USA (nationwide) in the states of CA and NV and the countries of: Canada, Venezuela, and the UK.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.