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

Additional Manufacturer Narrative

THE CURRENT COMPLAINT IS PENDING INVESTIGATION FROM ACON'S CONTRACT MANUFACTURER. ACON WILL SUBMIT A FOLLOW-UP MDR UPON INVESTIGATION COMPLETION. ANY ADDITIONAL INFORMATION RECEIVED BY ACON MAY BE INCLUDED WITH A FOLLOW-UP MDR.

Description of Event or Problem

FALSE NEGATIVE RESULT(S). THE USER REPORTED THAT THEY BEGAN TO EXPERIENCE SYMPTOMS (B)(6) 2026. TESTED WITH FF ON (B)(6) 2026. THAT RESULT WAS NEGATIVE. WENT AFTER ON (B)(6) 2026 TO A HEALTHCARE PROVIDER. MIGHT HAVE RECEIVED A PCR TEST BUT DOESN'T KNOW FOR SURE. THE RESULT WAS POSITIVE FOR RSV. THE USER'S SON AND WIFE BEGAN EXPERIENCING SYMPTOMS ON (B)(6) 2026 AND TESTED THEIR SON WITH FF ON (B)(6) 2026 AND THE RESULT WAS NEGATIVE. THEY TESTED THEIR SON WITH FF ON (B)(6) 2026 AND THE RESULT WAS NEGATIVE. PCR TESTED SON AT HEALTHCARE PROVIDER (B)(6) 2026 AND THE RESULT WAS POSITIVE FOR RSV. THE USER'S WIFE TESTED WITH FF AFTER ON (B)(6) 2026 AND THE RESULT WAS NEGATIVE. THEY SUSPECT WIFE ALSO HAS RSV BUT SHE HAS NOT RECEIVED A TEST FROM A HEALTHCARE PROVIDER. PURCHASED FROM WALGREENS.