Safety Alert for Trade Name: COBAS B 123 POC SYSTEM /// registration 10287410948 /// class I-low risk //// Lot-series 00200276 to 00200787

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.

Recommendations for users and patients: ACTIONS TO BE ADOPTED BY THE CLIENT / USER - If the product is not in the Serial Number range between 00200276 and 00200787, it has not been affected and can normally be used for sodium (Na +) measurement. - If batch affected 21560883 with serial numbers 00200276 to 00200787 of cobas b 123 Sensor Cartridge BG / ISE / GLU / LAC is currently in use, remove and replace with a new batch. - The replacement of the affected items from lot 21560883 and SN from 00200276 to 00200787 may be requested from Roche Diagnóstica Brasil Ltda. To request a replacement: 1) Complete the form contained at the end of the field action notification and send to the email brasil.tecnovigilancia@roche.com 2) After sending the form, contact our Customer Service Center (CEAC) ) 08007720295 and open a reset call by referencing this notification (SBN-CPS-2016-014). - For identification of the Lot and SN, see notification letter, Appendix 1. #### Update of the field action: UPDATED ON 10/27/2017, the company presented the report of completion of the field action, sending evidence and necessary corrective actions.