FLOWFLEX PLUS RSV + FLU A/B + COVID HOME TEST
Received Mar 12, 2026 · Event occurred Mar 9, 2026
Report 2531491-2026-00078 · MDR key 24582681
Device
Generic name
Covid-19 Multi-analyte Antigen Device
Manufacturer
Acon Laboratories, Inc.Product problems
- False Negative Result
Patient
NA · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
FALSE NEGATIVE RESULT(S). THE CUSTOMER HAS JUST PURCHASED THE TEST KITS FROM CVS. WHEN THE CUSTOMER PERFORMED 3 TESTS CORRECTLY, THE RESULTS WERE NEGATIVE FOR RSV FOR ALL 3 TESTS. THE CUSTOMER HAD FOLLOWED UP WITH THE DOCTORS AND TESTED POSITIVE FOR RSV. THE CUSTOMER HAS THROWN AWAY THE BOXES AND TEST CASSETTES, SO WE COULD NOT COLLECT THE LOT NUMBER & EXPIRATION DATE OFF THE BOX. CUSTOMERS COULD NOT PROVIDE PICTURES OF THE TEST CASSETTES IN QUESTION; THEY HAD BEEN THROWN AWAY.
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.