Commercial name: cobas b 123 <4> POC system Technical name: Analyzer For Ph and Gases Registration number ANVISA: 10287410948 Hazard class: I Model affected: cobas b 123 POC system with software system version 4.7 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 to be taken by the client / user 1) Update for software version 4.8 for the cobas system b 123 POC; 2) If the client is dosing neonatal bilirubin with the software version SW 4.7 and the immediate update to the SW version 4.8 is not possible, he / she should use the solution described below (see images in the notification): Configuration of correlation factors in the system cobas b 123 POC with software version SW V4.7: On the "Tools" tab, select "Configuration". In the configuration options, select "Measurement" -> "Correlations". First, check whether there are already established correlation factors for neonatal bilirubin to establish a correlation for another device with SW V4.7. (a) If there are no previously established correlation factors for neonatal bilirubin, proceed as follows: Select "New", and select the "Bili" Parameter and Sample Type "Blood". If the unit of Bilirubin is mg / dL, enter 1.6 mg / dL as Offset. If the μmol / L unit is used, enter the Offset as 27.36 μmol / L. Then enter the Slope as "0.85". After checking the values, press "OK" and confirm with "OK". (b) If previous correlation factors exist, proceed as follows: • If previous correlation values ​​have already been established with SW V4.7, it may be desirable to maintain this correlation. • If previous correlation factors were established with SW V4.5 prior to upgrading to SW V4.7, it is necessary to adapt the correlation factors to have the same correlation as established with software V4.5: slope V4.7 = slope V4.5 / 0.85 offset V4.7 [mg / dL] = offset V4.5 [mg / dL] - slope V4.5 * 1.88 [mg / dL] resp. offset V4.5 [μmol / L] = offset V4.5 [μmol / L] - slope V4.5 * 32.19 [μmol / L] Where slope V4.5 = slope that was established with SW V4.5 offset V4. 5 = offset that was established with SW V4.5 slope V4.7 = new slope to be calculated and inserted with SW V4.7 offset V4.7 = new offset to be calculated and inserted with SW V4.7 Insert these as described in the previous section. After entering the correlation factors, all measurement results for Bilirubin are marked with a "(c)" on the results screen, in the printed report, and in the detailed view of the database. Important Note: Changes in correlation factors as part of the workaround described above must be manually reversed after upgrading to SW V4.8. Factors are not automatically adapted or reversed in the course of software update. #### 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.