FDA Adverse Event Malfunction Summary report: N

INDICAID COVID-19 RAPID ANTIGEN AT HOME TEST

MDR report key: 23730773 · Received December 5, 2025

Report

Report Number
MW5180036
Event Type
Malfunction
Date Received
December 5, 2025
Date of Event
November 19, 2025
Report Date
November 30, 2025
Manufacturer
PHASE DIAGNOSTICS
Product Code
QKP
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I USED AN INDICAID AT HOME COVID TEST AS A PRECAUTION BEFORE SEEING FAMILY. I PERFORMED ALL STEPS OF TESTING PROPERLY, AND A VERY FAINT LINE APPEARED, INDICATING THE TEST WAS POSITIVE. I HAD COVID 11 WEEKS PRIOR, SO I WAS SURPRISED THOUGH I KNEW IT'S NOT IMPOSSIBLE. I WENT ONLINE TO ORDER MORE TESTS AND READ SEVERAL 1-2 STAR REVIEWS ON AMAZON OF OTHER PEOPLE REPORTING FALSE POSITIVES AND FAINT LINES LIKE MINE. I ISOLATED AND OVER THE NEXT FEW DAYS I TESTED NEGATIVE 6 TIMES WITH TESTS FROM OTHER BRANDS (THIS INCLUDED ONE TEST IMMEDIATELY FOLLOWING THE FALSE POSITIVE, ANOTHER THAT EVENING, AND THE REST OF THE TESTS WERE OVER THE COURSE OF THE NEXT FEW DAYS). THIS WAS CLEARLY A FALSE POSITIVE. I WROTE TO THE COMPANY WHO SUGGESTED IT WAS VIRAL SHEDDING FROM MY INFECTION WEEKS AGO, WHICH IS NOT POSSIBLE WITH AN ANTIGEN TEST OR WITH THAT LENGTH OF TIME.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2422992 INDICAID COVID-19 RAPID ANTIGEN AT HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP PHASE DIAGNOSTICS 24100054

Patients

Seq Age Sex Outcome Treatment
1 38 YR Female BIRTH CONTROL.| LEVO-THYROXINE.