BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON/GO AT-HOME COVID-19 RAPID ANTIGEN SELF-TEST

    MDR report key: 13560215 · Received February 17, 2022

    Report

    Report Number
    MW5107550
    Event Type
    Malfunction
    Date Received
    February 17, 2022
    Date of Event
    February 15, 2022
    Report Date
    February 15, 2022
    Manufacturer
    ACCESS BIO. INC
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    (B)(6)-PURCHASED "ON/GO AT-HOME COVID-19 RAPID ANTIGEN SELF-TEST, 2 TESTS PER PACK, TEST RESULTS IN 10 MINUTES, FDA EUA AUTHORIZED, EXPIRATION EXTENDED" APPEARS TO BE "ACCESS BIO CARESTART COVID-19 ANTIGEN HOME TEST." UNABLE TO FIND INFORMATION RE. THIS TEST BY SEARCHING FOR "ON/GO," "ACCESS BIO," OR "INVITRIO" ON FDA.GOV WEBSITE. THE LETSONGO.COM WEBSITE STATES THAT "AS OF (B)(6) 2021, ON/GO TM COVID-19 ANTIGEN HOME TEST IS AUTHORIZED TO USE WITH INDIVIDUAL ANTERIOR NASAL SWAB SPECIMENS FROM INDIVIDUALS AGE 14 YEARS AND OLDER (SELF-COLLECTED), OR 2 YEARS AND OLDER (COLLECTED WITH ADULT ASSISTANCE) FOR NON-PRESCRIPTION HOME USE BY FDA UNDER THE EUA ((B)(4))." HOWEVER, A SHELF-LIFE EXTENSION AUTHORIZATION LETTER FROM THE FDA ON JANUARY 20, 2022 REPRODUCED ON THAT WEBSITE IS FOR THE "CARESTART COVID-19 ANTIGEN HOME TEST," AND DOES NOT MENTION "ON/GO." USER COMMENTS ON (B)(6) INDICATE 1,045 POSITIVE REVIEWS VS. 1,682 CRITICAL REVIEWS COMPLAINING ABOUT INCORRECT TEST RESULTS, EXPIRED TESTS, FAILED TESTS, AND CRITICAL DIFFICULTIES USING THE ASSOCIATED IPHONE APP. ALTHOUGH IT MAY WELL BE THAT ALL OF THIS IS ABOVE-BOARD, I FIND IT DIFFICULT TO HAVE CONFIDENCE IN THIS TEST, AND HOPE YOU WILL BE ABLE TO TAKE ANY INDICATED ACTIONS IF YOU ARE ABLE TO INVESTIGATE. FDA SAFETY REPORT ID # (B)(4).

    Description of Event or Problem · 0

    (B)(6)-PURCHASED "ON/GO AT-HOME COVID-19 RAPID ANTIGEN SELF-TEST, 2 TESTS PER PACK, TEST RESULTS IN 10 MINUTES, FDA EUA AUTHORIZED, EXPIRATION EXTENDED" APPEARS TO BE "ACCESS BIO CARESTART COVID-19 ANTIGEN HOME TEST." UNABLE TO FIND INFORMATION RE. THIS TEST BY SEARCHING FOR "ON/GO," "ACCESS BIO," OR "INVITRIO" ON FDA.GOV WEBSITE. THE LETSONGO.COM WEBSITE STATES THAT "AS OF (B)(6) 2021, ON/GO TM COVID-19 ANTIGEN HOME TEST IS AUTHORIZED TO USE WITH INDIVIDUAL ANTERIOR NASAL SWAB SPECIMENS FROM INDIVIDUALS AGE 14 YEARS AND OLDER (SELF-COLLECTED), OR 2 YEARS AND OLDER (COLLECTED WITH ADULT ASSISTANCE) FOR NON-PRESCRIPTION HOME USE BY FDA UNDER THE EUA ((B)(4))." HOWEVER, A SHELF-LIFE EXTENSION AUTHORIZATION LETTER FROM THE FDA ON JANUARY 20, 2022 REPRODUCED ON THAT WEBSITE IS FOR THE "CARESTART COVID-19 ANTIGEN HOME TEST," AND DOES NOT MENTION "ON/GO." USER COMMENTS ON (B)(6) INDICATE 1,045 POSITIVE REVIEWS VS. 1,682 CRITICAL REVIEWS COMPLAINING ABOUT INCORRECT TEST RESULTS, EXPIRED TESTS, FAILED TESTS, AND CRITICAL DIFFICULTIES USING THE ASSOCIATED IPHONE APP. ALTHOUGH IT MAY WELL BE THAT ALL OF THIS IS ABOVE-BOARD, I FIND IT DIFFICULT TO HAVE CONFIDENCE IN THIS TEST, AND HOPE YOU WILL BE ABLE TO TAKE ANY INDICATED ACTIONS IF YOU ARE ABLE TO INVESTIGATE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2407745 ON/GO AT-HOME COVID-19 RAPID ANTIGEN SELF-TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACCESS BIO. INC RCPM-00279 CP21K14

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male