FLOWFLEX PLUS RSV + FLU A/B + COVID HOME TEST
Received May 11, 2026 · Event occurred May 1, 2026
Report 2531491-2026-00120 · MDR key 25144500
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). WE GOT A CALL FROM A CUSTOMER THAT IS HAVING AN ISSUE WITH THE FLOWFLEX PLUS 4 N1 COVID 19, FLU A/B, RSV ANTIGEN TEST KIT. THIS IS AN OUT OF BOX ISSUE. WHEN THE CUSTOMER PERFORMED THE TEST CORRECTLY, THERE WAS NO CONTROL LINE ON EITHER SIDE OF THE TEST CASSETTE. THE CUSTOMER SAID THERE WERE NO LINES VISIBLE AT ALL. THE CUSTOMER COULD NOT SEND A PICTURE OF THE TEST CASSETTE. THE CUSTOMER COULD NOT OPEN THE TEST CASSETTE TO TAKE A PICTURE OF THE INSIDE COMPONENT LAYOUT. THE CUSTOMER DOES NOT HAVE AN EMAIL ADDRESS AND CANNOT PROVIDE THE LOT NUMBER AND EXPIRATION DATE OFF THE KIT. I ADVISED THE CUSTOMER, I WILL FORWARD THE INFO TO ACON COMPLAINT TEAM FOR REVIEW.
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.