As part of agilent's continuous improvement process, our procedures were reviewed, and it was determined that there is a need to report potential risks associated with critical liquid dispense system components 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).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: probe leakage.No direct or indirect patient harm or user harm have been reported.
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