FLOWFLEX PLUS RSV + FLU A/B + COVID HOME TEST

Additional Manufacturer Narrative

THE CURRENT COMPLAINT IS RELATED TO PERFORMANCE ISSUE OR DEVICE MALFUNCTION, BUT NO INFORMATION WAS PROVIDED FOR ACON TO CONDUCT AN INVESTIGATION. ANY ADDITIONAL INFORMATION RECEIVED BY ACON MAY BE PROVIDED TO FDA IN A FOLLOW UP MDR.

Description of Event or Problem

FALSE NEGATIVE RESULT(S). CUSTOMER STATED THAT THE TEST IS NOT RELIABLE. SHE USED IT AND SHE HAD THE FLY AND TESTED NEGATIVE. THE DISPOSAL IS EASY AND ALL BUT NEEDS IMPROVEMENT.