Trade name: PreciControl Varia Technical name: MULTI-PARAMETER CONTROLS OF ONE OR MORE CONCENTRATIONS - CLASS II Registration number ANVISA: 10287410955 Hazard class: II Model affected: Serial numbers affected: 18928501 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 taken by Roche Diagnóstica: Lot 189285-01 of PC Varia, has been temporarily blocked for reworking and updating of the package insert (see updated package insert). The subsequent batch of PC Varia (221451) is already available at the factory for import. The limitation of the internal software, which caused the problem, has already been fixed. Actions to be taken by the customer / user The incorrect target value is only present in the PreciControl Varia, lot 189285-01, level 2, for the Elecsys PTH assay on the Elecsys 2010 / cobas and 411 analyzers. Users must enter the correct value manually, as supplied on the new Data Sheet attached to this communication: • A batch-specific reagent value has been provided for Elecsys PTH lot 143251. • For all other batches of Elecsys PTH (incl. be used. For further questions and support, please do not hesitate to call our CEAC Service Center - 08007720295 or your Roche Diagnostica Brasil Ltda representative. #### Update of the field action: UPDATED ON 10/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.