As part of our continuous improvement process, we have reviewed our procedures and determined that there is a need to increase the reporting of potential risks associated with leakage on the autostainer.We have assessed all autostainer dispense and leakage complaints from november of 2017 through march of 2020 that resulted in alteration in staining or potential alteration in slide staining.Following this review, it was decided to retrospectively file an mdr for customer complaint (b)(4) as mdr.This is an initial and final report combined.Summary: based on complaint report or investigated failure mode, there was potential for a staining alteration.Customer complaint record reported the event as follows: level sensing failure.No direct or indirect patient harm or user harm have been reported.
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