Trade name: Multiplate® Analyzer Technical Name: Multiplate® Analyzer ANVISA Registration Number: 10287411001 Hazard Class: I Affected Model: N / A Serial numbers affected: 100296 의 안전성 경고

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.

ACTIONS ADOPTED BY ROCHE DIAGNOSTICS Roche Diagnostics GmbH, the manufacturer of the product, is working with the highest priority to identify appropriate corrective actions to correct the defect. Roche Diagnostica Brazil has identified a single locally distributed serial number of potentially affected Multiplate® analyzer (SN 100296), manufacturing the affected stirring plate, and is communicating its affected customer via the Field Action Notification. Multiplate® analyzers manufactured after production of SN 100517 are unaffected. Roche Diagnostica is collecting more detailed data on potentially affected analyzers to plan, prioritize, and perform repair actions as soon as possible. ACTIONS TO BE ADOPTED BY THE CLIENT / USER • Stop using the potentially affected Multiplate® analyzer for diagnostic purposes (SN distributed in Brazil: 100296); • If you are contacted by Roche Diagnóstica Brasil or your local Field Engineer to provide information regarding your potentially affected Multiplate® analyzer, we request that the requested information be provided to allow for planning of corrections and prioritization of repair actions; • Once the data collection procedure is complete, each potentially affected Multiplate® analyzer will be evaluated by a Roche Representative to verify whether the analyzer is individually affected or not, since not all stirrer plates of this Multiplate® analyzer can develop an increase of stirring speed. Until this check, the Multiplate® analyzer must not be used for diagnostic purposes; • Confirmed Multiplate® analyzers as affected can only be used for diagnostic purposes after completion of the correction and repair actions. 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. #### UPDATED ON 08/22/2017, the company submitted completion report of the field action with proof of required registry changes.