The material number is not marketed or distributed in the us.However, roche observed unacceptable, light staining with some ventana pd-l1 (sp142) on-market lots, during internal comparison studies.Light staining affects the borderline of positive versus negative test results.An on-going investigation has determined the root cause is related to variability in the selection of antibody concentration in raw materials, affecting specific ventana pd-l1 (sp142) assay lots made with the impacted raw materials.A notification has been sent to us customers informing them of the issue to immediately discontinue the use of and discard any remaining inventory of specific impacted lots and informing of an updated date of expiration for certain lots.The alleged sample was initially tested on 24 feb 2022 and was repeated on 21 dec 2022 after receiving the notification.E1 facility name truncated due to character limit: sgh - histopathology laboratory (b)(6) hospital pte ltd.
|