Trade Name: ChoiceLine 10 Technical Name: URINE TEST TAPE ANVISA Registration Number: 10287410230 Hazard Class: II Model Affected: Serial Numbers Affected: ChoiceLine 10 lots in Brazil (distributed + stock): 11517901; 11517902; 20203401; 20203402; 20339301; 20339302; 22451002; 22933201; 22933202; 23203301; 23203302. 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.

RECOMMENDATION TO USERS / CUSTOMERS: 1) Please note that the following corrected text should be considered in the use instruction: In the "Accuracy" section of the usage instruction table, the correct classification of the bacteria should read as: Nitrite: = 90 % to 10 ^ 7 gram negative organisms compared to the Griess test. The result of product performance is not affected by the incorrect information contained in the use instruction, so the products can continue to be used as specified. 2) Please fill in the form contained at the end of this notification and send to brasil.tecnovigilancia@roche.com e-mail For further questions and support, please do not hesitate to call our CEAC Service Center - 08007720295 or your representative Roche Diagnóstica Brasil Ltda.