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

INVALID RESULT(S): INVALID RESULT. THE END USER REPORTED THAT THEY DID NOT RECEIVE A CONTROL (CTL) LINE ON THE STRIP FOR COV/FLU. THE STRIP FOR RSV PRODUCED A CONTROL (CTL) AND TEST (R) LINE. PURCHASED FROM WALGREENS.