On (b)(6) 2021, the customer reported to leica biosystems that patient tissue was undiagnosable due to sectioning issues with the instrument leica cm1860.Leica biosystems requested additional information regarding the event; however, the customer declined to provide any additional details or information regarding the undiagnosable patient tissue.Furthermore, the customer provided the following email response to leica biosystems on 18 october 2021, "in following up with our risk team we are submitting smda so you will be able to get that information through that system" and "at this time we will decline to provide further details at the recommendation of our risk department." if leica biosystems receives additional information, a follow up report will be submitted.
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