Field Safety Notices about OptiView DAB IHC Detection Kit

Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.

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, continue to use system-level controls as directed in the Package Insert. Ventana recommends that for p16/Ki-67 Dual-stain negative cases, customers evaluate slides for signs of specific DAB staining of cells, such as the staining of metaplastic cells. This will ensure that the DAB detection chemistry was properly dispensed. In cases where there is no specific brown DAB staining observed, and there are morphologic features suggesting moderate to severe dysplasia in cells showing specific red nuclear staining for Ki-67, customers should retest the specimens that may be potentially false negative as a result of a dispenser malfunction. In order to reduce the risk of this issue impacting patient care, customers should follow their local procedures and policies regarding retrospective re-testing, applying the guidance above. Any re-testing should be limited to assays performed with the affected lots. 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 local procedures and policies regarding retrospective retesting, especially for IHC assays and cases that do not contain a biologic internal control. Any retesting should be limited to assays performed with the infected lots.