FDA Adverse Event Injury Summary report: N

ACON LABS FLOWFLEX COVID 19 ANTIGEN HOME TEST

MDR report key: 19992468 · Received August 14, 2024

Report

Report Number
MW5158416
Event Type
Injury
Date Received
August 14, 2024
Date of Event
August 10, 2024
Report Date
August 12, 2024
Manufacturer
ACON LABORATORIES, INC.
Product Code
QKP
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
WA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

TWO ACON LABS FLOWFLEX COVID-19 ANTIGEN HOME TEST KITS FROM THE SAME LOT PRODUCED INVALID RESULTS (NO CONTROL LINE). A THIRD KIT FROM A DIFFERENT LOT PRODUCED AN INSTANTLY POSITIVE RESULT. I AM IMMUNOSUPPRESSED. THANK GOODNESS I HAD THE THIRD KIT BECAUSE I AM NOW ON PAXLOVID AND IN THE MIDDLE OF COVID, HOPING ALL GOES WELL. ACON LAB'S RESPONSE WAS LACKADAISICAL AND DISMISSIVE. IT REFUSED TO REPLACE THE UNUSED DEFECTIVE TEST KITS AND DID NOT ACCEPT ANY RESPONSIBILITY FOR THE POOR QUALITY CONTROL THAT LED TO THEIR RELEASE. WHO KNOWS HOW MANY MORE DEFECTIVE KITS ACON HAS RELEASED? ALMOST CERTAINLY, THIS ONE LOT IS ENTIRELY DEFECTIVE, AND THIS LOT IS OUT IN PHARMACIES AND RETAIL STORES NOW. MOST PEOPLE WILL NOT UNDERSTAND THAT THEY HAVE A BAD TEST KIT AND NOT A NEGATIVE TEST RESULT, CAUSING FURTHER SPREAD OF COVID IN THE CURRENT WAVE. THIS KIND OF BEHAVIOR FROM A MANUFACTURER SHOULD NOT BE TOLERATED AND SHOULD BE HEAVILY PUNISHED. THANK YOU. YOU CAN SEE THE LOT NUMBER IN THE PHOTOS I HAVE. I ALSO HAVE TODAY'S EMAIL COMMUNICATION (TRIGGERED BY A PHONE CALL ON SATURDAY) WITH ALCON. IT'S NOT CLEAR WHICH NUMBER BELONGS WHERE. WHY DOES THIS MATTER FOR A TEST KIT? REF REPORT: MW5158417.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1163486 ACON LABS FLOWFLEX COVID 19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC. (01)00682607660261 COV3090005

Patients

Seq Age Sex Outcome Treatment
1 67 YR Male Other| S| R