MalfunctionSCA

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

Received Apr 30, 2026 · Event occurred Apr 17, 2026

Report 2531491-2026-00115 · MDR key 25049034

Device

Generic name

Covid-19 Multi-analyte Antigen Device

Manufacturer

Acon Laboratories, Inc.

Product problems

Unable to Obtain Readings

Patient

NA · Unknown

Insufficient Information

Narrative

Description of Event or Problem

INVALID RESULT(S). CUSTOMER STATED THAT USED 2 TESTS AND ONE WAS DEFECTIVE.

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.