SPOT-Light" HER2 CISH Kit, catalog #84-0150, 20 tests/kit, labeled in part ***Invitrogen Corporation 7335 Executive Way

FDA device recall Z-0461-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Life Technologies Corporation

Reason for recall

In vitro diagnostic reagent may be contaminated with a fungal contaminant.

Action taken

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.

Root cause

Material/Component Contamination

Status

Terminated

Product code

NYQ

Quantity affected

29 kits

Distribution

Worldwide Distribution - USA (nationwide) in the states of CA and NV and the countries of: Canada, Venezuela, and the UK.

Date initiated

2011-11-14

Date posted

2012-01-11

Date terminated

2012-02-10

Location

Frederick, MD