MalfunctionSCA

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

Received Mar 12, 2026 · Event occurred Mar 6, 2026

Report 2531491-2026-00077 · MDR key 24582010

Device

Generic name

Covid-19 Multi-analyte Antigen Device

Manufacturer

Acon Laboratories, Inc.

Product problems

False Negative Result

Patient

NA · Unknown

Insufficient Information

Narrative

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): FALSE NEGATIVE WITH COVID.