The investigation revealed the following: the incident was presumably user related due to a wrong application from the customer site.The customer processed the tissues, which were all different sizes (some small biopsies), using the "standard tissue overnight" protocol.It is recommended to use at least 5mm (thickness) tissues for the overnight tissue processing protocol, therefore it was determined the customer used the incorrect protocol for processing small tissue biopsies.Following the investigation of the instrument logs and tissue processing information provided by the customer, the leica biosystems (b)(4) applications department determined the use of the incorrect protocol for the size of the tissues processed may result in underprocessed tissue.The image provided by the customer showed that the fatty tissue was still yellow.Additionally, the customer is using sub-x as a xylene substitute in combination with autorotation function.Leica biosystems (b)(4) does not have a validated protocol with sub-x for the (b)(4) instrument.Therefore leica biosystems (b)(4) cannot provide nor recommend any protocol for use of sub x on the (b)(4).A customer facing letter will be sent to the customer with a recommendation in the future of how to properly care for the tissues, reagents and protocols during the processing with the tissue processor.
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