Alerta De Seguridad para CELL-DYN 1700, Registration 10055310574 - CELL-DYN 1700 CS, Registration 10055310576 - CELL-DYN 1600 CS (120v) Registration 10055310125 - CELL-DYN 1600 CS (220v) Registration - 10055310125 - CELL-DYN 1400, c / RS 232 Registration 10055310122 - CELL-DYN 1400 CS Registration 100553105122 and CELL-DYN 1400 Registration 10055310122

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.

Note the existence of abnormal platelet histogram with an MCV <7) fl parameter, as it may be a case of microcytosis and thrombocytopenia, with no URI alert message appearing. According to the results, of red blood cells and platelets, by an alternative manual or automatic method, according to the laboratory procedure. The platelet histogram demonstrates a normal or typical platelet histogram, which should be considered as the visual validation criterion of the result. As well as, patient boundaries indicate an abnormality of outcome, and are used to repeat and confirm by alternative methods manual or automated, according to the laboratory procedure. You are requested to: Keep a copy of the communication received in your files and attached to the CEL-DYN 1400, 1600 and 1700 instrument manuals. Forward a copy of the communication to the physician. Fill in the RESPONSE PROTOCOL and send the Customer Service Center. Any additional questions or clarifications, please contact the Customer Service Center, Telephone 0800 119099