Safety Alert for Trade name: OptiView DAB IHC Detection Kit; Ultraview Universal DAB Detection Kit; OptiView Amplification Kit and Hematoxylin II. Technical Name: Immunohistochemistry - Complementary Reagents. ANVISA Registration Number: 10287410832. Hazard Class: I. Affected Model: N / A .. Serial Numbers Affected :. >> Lots Affected Distributed by Roche Diagnóstica Brazil :. OptiView DAB IHC Detection Kit = Lot Y11625. UltraView Universal DAB Detection Kit = Y09284. OptiView Amplification Kit = Lot Y15435. Hematoxylin II = Lot Y13938. >> Lots Affected in Stock in Roche Disgnóstica Brazil :. OptiView DAB IHC Detection Kit = Lots Y11625; Y15571; Y19271. ultraView Universal DAB Detection Kit = Lots Y09284; Y11687; Y15384; Y17984; Y18099. OptiView Amplification Kit = Lot Y15435. Hematoxylin II = Lots Y13938; Y17402; Y17403. NOTE: In the origin (manufacturer) there are other materials and lots affected, but that have not been imported by Brazil so far.

Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.

> Roche Diagnostica Brazil advises that affected kits already distributed may continue to be used by customers until the manufacturer-corrected product is available provided that the affected IHC detection kits (iView, Ultraview, OptiView) are used together on the same blade of the controls as described in the operating instructions. These controls should be appropriate for each assay and capable of detecting false negative results due to potential failure of complete or partial dispensing of the reagent. > For trials that are directly related to clinical therapeutic decision making (eg ER / PR, HER2, ALK, etc.), this action is additionally important to select a positive control tissue on the same slide with sufficient sensitivity to detect small decreases in intensity that can cause positive borderline cases appearing as negative (eg HER2 2+ vs 1+). Although the use of controls on the same blade is considered an ideal laboratory practice strongly recommended by Ventana, customers can revert to standard execution controls when the unaffected product is provided. > In order to reduce the risk of this problem that can affect patient care, clients who do not use controls on the same slide as a standard practice should follow their local procedures and policies for retrospective retest, especially for IHC trials and in cases which do not contain an internal biological control. Any further testing should be limited to testing performed on affected batches. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 12/19/2017 - Date of notification notice to Anvisa: 01/15/2018 The company that owns the affected product is responsible for contacting its customers in due time. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "