Alerta De Seguridad para CREATININA - Registered in Anvisa under the number 80115310057 - Lots: 1073230945 (Creatinine R1 2x200ml + R2 1x100ml + 1x3ml Standard) and 1070890942 (Creatinine R1 1x200ml + R2 1x50ml + 1x3ml Standard) - Kovalent do Brasil Ltda.

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.

It is important to note that clinical laboratories use controls capable of identifying this type of quality deviation, since changes in creatinine levels may indicate renal impairment. By means of the traceability of the affected lots, the communication was made to the customers (see annex), informing them of the fact. The process of collecting the lots is already underway and Anvisa follows the process. ### The company informed the closing of the field action through file 842387 / 09-3 of 10/27/2009.