Trade name: Vidas 3 Technical name: Lives 3 ANVISA registration number: 10158120679 Hazard class: I Affected name: Not applicable 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.

1.1- "Error code 0550CAPU1" displayed in case of tip loss does not suggest the appropriate error solution. Required Actions: In case of error message "error 0550 risk of contamination", associated with loss of tip during sample aspiration: - Do not follow the instructions provided by the instrument. - Call bioMérieux right away. - The System must be decontaminated by the Engineering Service of bioMérieux before use. 1.2- For customers using automatic pipetting mode: "error code 0400FAPU1" not justified. Actions Required: Check if sample volume is above dead volume (indicated in user manual): - If there is not enough sample, error 400 is justified and there is no impact. Follow the instructions provided by the instrument. - If there is a sufficient sample, please apply the following actions: - Stop using the machine in automatic mode, and use only the manual pipetting mode. - Discard all processed loaded tubes at the same time as the affected sample. - Conduct a retrospective analysis of the results of these samples, including those sent to the LIS. - Call bioMérieux. 1.3- Stopping the section during the analytical phase may induce the falling of the bar inside the apparatus. Actions Required: When a section is stopped for any reason (section stop, door open, alarms or power failure) during the analytical phase, please decontaminate the pipetting block and the tray of the barrels following the decontamination procedure described in the user guide. (SPR® Block Cleaning and Section Barrier Tray Cleaning). We also recommend that you avoid stopping a section during the analytical phase (stop button or door opening during the test). 1.4- Only for customers who manage their internal or external Quality Control via VIDAS®3 Quality Control Module. Required Actions: We recommend that you avoid modification of name, full name and / or level of Quality Control. Actions Required from the administrative point of view of the laboratory: - Please distribute this information to all appropriate personnel in your laboratory, keep a copy in your files and send this information to all parties who may use this product, including others to whom you may have sent / downloaded our product. - Apply the necessary actions described above and associated with each described limitation. - Discuss any questions you may have regarding previously reported results with your Laboratory Medical Officer to determine the course of action required. - Fill out and return the Acknowledgment Form in Appendix A to confirm receipt of this notice. ### Field Action Update: UPDATED ON 10/25/2017, the company submitted the field action completion report verifying the submission of the customer safety warning with evidence from science and all actions completed.