It will most definitely be a problem during any CAP inspection because the FDA procedure is approved for fixation with formalin exclusively.
Also the alcohols contained in Pen Fix (methanol, ethanol and 2-propanol) will probably affect the antigen preservation in a specimen that with 6 hours fixation is only 28% crosslinked with the formaldehyde. It is much better to leave breast specimens in 10% NBF especially if you have the opportunity of leaving them overnight.
René J.

--- On Thu, 7/3/08, Sharon Campbell  wrote:

       
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