Recall Z-0737-2018

Reason for recall

Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II.

FDA-determined cause: Process control

Action taken

On Dec 19th all Roche affiliates (the direct consignees) worldwide were notified via Safety Board Notification (SBN) and subsequent Field Safety Notification (EX-US) and UMDC TD00090 (US) SBN and FSN revised Dec 20th due to 3 affected part numbers missed on original letter. The instructions are as follows: "Actions taken by Roche Diagnostics All affected product has been placed on hold. Ventana has reworked all product in its inventory and is in the process of manufacturing new lots for distribution and replacement of customer affected kits. Customers will be notified when corrected product is available. Actions to be taken by the customer/user Affected kits may continue to be used by customers until corrected product is available, however Ventana is mandating that the affected IHC detection kits (iView, ultraView, OptiView) must only be used in conjunction with same-slide controls. These controls must be appropriate for each assay and capable of detecting false negative results due to a complete or partial reagent dispense failure. CINtec PLUS Cytology does not have the capacity for same slide controls, so system-level controls should be maintained. ultraView SISH Detection is used for HER2 analysis, and employs internal positive controls; no external control is required. For assays that directly relate to clinical therapy decision making (e.g. ER/PR, HER2, ALK, etc.), it is additionally important to select a same slide positive control tissue with sufficient sensitivity to detect small decreases in intensity that may cause borderline positive cases to appear as negative (e.g. HER2 2+ vs. 1+). Although the use of same slide controls is considered optimal laboratory practice and strongly recommended by Ventana, customers may revert to standard run controls once non-impacted product is received. In order to reduce the risk of this issue impacting patient care, customers not using same slide controls as a standard practice should follow their