BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUATE COVID-19 & FLU A/B ANTIGEN TEST

    MDR report key: 23930076 · Received December 30, 2025

    Report

    Report Number
    3009238284-2025-00003
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    December 16, 2025
    Report Date
    January 14, 2026
    Manufacturer
    HEALGEN SCIENTIFIC LLC
    Product Code
    SCA
    PMA / PMN Number
    DEN240029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER HAS COMPLETED THE INVESTIGATION. RETAINED SAMPLES FROM THE AFFECTED LOT IN USE AT THE TIME OF THE REPORTED EVENT WERE EVALUATED. TESTING WAS PERFORMED IN ACCORDANCE WITH ESTABLISHED AND VALIDATED PROCEDURES, AND NO ANOMALIES OR IRREGULARITIES WERE OBSERVED. ALL TESTED DEVICES MET APPLICABLE ACCEPTANCE CRITERIA AND PERFORMED AS INTENDED. NO PRODUCT-RELATED ISSUE WAS IDENTIFIED. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED BASED ON THE RESULTS OF THE INVESTIGATION. NOTE: THIS IS THE FINAL REPORT.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED A SUSPECTED FALSE NEGATIVE RESULT AFTER TESTING HERSELF AND HER MOTHER TWICE ON (B)(6) 2025) USING THE EQUATE COVID-19 & FLU A/B ANTIGEN TEST, WITH ALL RESULTS NEGATIVE FOR COVID AND FLU A/B. DUE TO PERSISTENT SYMPTOMS, SHE SOUGHT MEDICAL CARE ON (B)(6) 2025 AND REPORTED A POSITIVE COVID RESULT AT A HEALTHCARE PROVIDER'S OFFICE; HOWEVER, THE TEST METHOD USED BY THE PROVIDER WAS NOT CONFIRMED BY THE CUSTOMER.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED A SUSPECTED FALSE NEGATIVE RESULT AFTER TESTING HERSELF AND HER MOTHER TWICE ((B)(6) 2025) USING THE EQUATE COVID-19 & FLU A/B ANTIGEN TEST, WITH ALL RESULTS NEGATIVE FOR COVID AND FLU A/B. DUE TO PERSISTENT SYMPTOMS, SHE SOUGHT MEDICAL CARE ON (B)(6) 2025 AND REPORTED A POSITIVE COVID RESULT AT A HEALTHCARE PROVIDER'S OFFICE; HOWEVER, THE TEST METHOD USED BY THE PROVIDER WAS NOT CONFIRMED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2272597 EQUATE COVID-19 & FLU A/B ANTIGEN TEST MULTI-ANALYTE RESPIRATORY VIRUS ANTIGEN DETECTION TEST SCA HEALGEN SCIENTIFIC LLC 2509025DEN

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female