Press Release
New Reagent Formulation Change to be Provided in GTI Diagnostics ELISA Assays ®DonorScreen-HLA Class I and Class II
June 1, 2010
IMPORTANT PRODUCT NOTICE:
NEW REAGENT FORMULATION CHANGE TO BE PROVIDED IN GTI DIAGNOSTICS ELISA ASSAYS
®DonorScreen-HLA Class I and Class II
A formulation change to the Stopping Solution has been identified for GTI Diagnostics’ ELISA-based assays. The new solution will eliminate hazards that are associated with the current reagent, as well as eliminate special chemical disposal needs.
Extensive validation testing has been performed. The new Stopping Solution does not change the product, its performance or the test procedure.
It is expected that ELISA kits containing the new Stopping Solution will be distributed when the current stock has been depleted. The new kits will be labeled with a bright pink sticker stating “New Stopping Solution Formulation. See enclosed CD for changes”. The Direction Insert on the CD will contain the changes highlighted in yellow.
A revised Direction Insert and MSDS will be posted on the GTI Diagnostics Website (www.gtidiagnostics.com) before the kits with the new Stopping Solution will be available for distribution. These documents may be used to update any internal procedures you have that may be affected.
Please contact GTI Diagnostics Technical Support, your Technical Sales Specialist or Distributor if you have any questions regarding this change.
800.233.1843 In USA
262.754.1000 Tel
262.754.9831 Fax
techsupport@gtidiagnostics.com
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