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). I KNOW THEY SAY NOT AS ACCURATE AS DR OFFICE, BUT I'VE NEVER HAD COVID OR FLU AND IT NOT SHOW UP HERE. IF YOU ARE GETTING THIS FOR RSV DON'T I'M CONFIRMED AND IT DID NOT SHOW AT ALL. MY TEST TURNED QUICKLY AT DR OFFICE SO IT'S NOT FOR LACK OF MARKERS.