Recall Z-0461-2012 ยท NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
Life Technologies Corporation
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 pat
| Date | Jan 11, 2012 (initiated Nov 14, 2011) |
| Status | Terminated |
| Reason | In vitro diagnostic reagent may be contaminated with a fungal contaminant. |
| Root cause | 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 thei |
| Quantity | 29 kits |
| Distribution | Worldwide Distribution - USA (nationwide) in the states of CA and NV and the countries of: Canada, Venezuela, and the UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.