The user purchased two packages (four tests) of the covid-19 ag home test and tried using one of those tests, and got the error message shown in the photo attached.The user then tried each of the remaining three tests and received the same error message.The error message says that the tests cannot be used because they "expired" on (b)(6).The problem of course is that today is (b)(6).Therefore, the user asked to contact to rectify this situation.Importer comments: this is a phenomenon that occurs because the serial number of the product and the application for activation are not synchronized.There is no error with the diagnosis of covid-19 but activation of the application through qr code is part of the product's functionality so that we assessed this is in criteria of "malfunction" according to the 21cfr803.
|