Replacing Components in an IVD Reagent Kit

M

Mare74

#1
A customer has spilled a buffer that comes in a IVD reagent kit. The spilled buffer lot is available as a GPR (General Purpose Reagent). The remaining components of the reagent kit have been functionally QC'd as a system so can we replace the buffer as long as it's the same lot as the one spilled?
 
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#3
A customer has spilled a buffer that comes in a IVD reagent kit. The spilled buffer lot is available as a GPR (General Purpose Reagent). The remaining components of the reagent kit have been functionally QC'd as a system so can we replace the buffer as long as it's the same lot as the one spilled?
I don't think you will find anyone from outside your company that is quialified to answer this one, because it will bepend on your traceability system and QC-procedures. In my company the answer would be "yes, you can", but really you should confirm this within your own organization.
 
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