BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 23660128 · Received November 26, 2025

    Report

    Report Number
    1221359-2025-00844
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    January 1, 2020
    Report Date
    January 19, 2026
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QYT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. D. SUSPECT MEDICAL DEVICE [D1 - BRAND NAME, D2A - COMMON DEVICE NAME, D2B - PROCODE, D4 (LOT #, CATALOG #, EXPIRATION DATE, PRIMARY UDI NUMBER)]: THIS REPORT IS BEING SUBMITTED FOR AN UNSPECIFIED ABBOTT SWAB PRODUCT RELATED TO THE EVENT. THE REQUIRED INTAKE DETAILS, SUCH AS THE KIT LOT NUMBER AND PRODUCT CODE, WERE NOT PROVIDED. BASED ON AVAILABLE INFORMATION, THE PRODUCT POTENTIALLY INVOLVED MAY BE BINAXNOW COVID-19 AG SELF-TEST (195-160) OR ID NOW COVID-19 2.0 TEST KIT (192-000) OR BINAX NOW COVID-19 AG CARD KIT (195-000) AND D1 (BRAND NAME), D2A (COMMON DEVICE NAME) AND D2B (PROCODE) REFLECT THESE PRODUCTS. ABBOTT MEDICAL AFFAIRS WAS CONSULTED REGARDING THE POSSIBILITY OF THE SAMPLE SWABS CAUSING EAR INFECTIONS AND CONFIRMED THAT A STERILE NASAL SWAB CANNOT CAUSE AN EAR INFECTION. THEY INDICATED IT IS MORE LIKELY THAT THE CUSTOMER ALREADY HAD AN UNDERLYING INFECTION THAT LED TO BOTH THE SYMPTOMS PROMPTING THE COVID-19 TEST AND THE SUBSEQUENT EAR INFECTION. THE PATIENT ALSO REPORTED EAR IRRITATION DURING SAMPLE COLLECTION, WHICH MAY HAVE BEEN AN EARLY SIGN OF THE DEVELOPING EAR INFECTION. THE CUSTOMER COULD NOT PROVIDE INFORMATION FOR INVESTIGATION, SUCH AS THE EXACT ABBOTT COVID-19 PRODUCT NAME OR LOT NUMBER. THE REQUIRED INTAKE INFORMATION TO ENABLE FURTHER INVESTIGATION, SUCH AS THE KIT'S LOT NUMBER, WAS NOT PROVIDED AND AN INVESTIGATION WAS NOT ABLE TO BE PERFORMED. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUES AS NO INFORMATION WAS PROVIDED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    B3: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. D. SUSPECT MEDICAL DEVICE [D1 - BRAND NAME, D2A - COMMON DEVICE NAME, D2B - PROCODE, D4 (LOT #, CATALOG #, EXPIRATION DATE, PRIMARY UDI NUMBER)]: THIS REPORT IS BEING SUBMITTED FOR AN UNSPECIFIED ABBOTT SWAB PRODUCT RELATED TO THE EVENT. THE REQUIRED INTAKE DETAILS, SUCH AS THE KIT LOT NUMBER AND PRODUCT CODE, WERE NOT PROVIDED. BASED ON AVAILABLE INFORMATION, THE PRODUCT POTENTIALLY INVOLVED MAY BE BINAXNOW COVID-19 AG SELF-TEST (195-160) AND D1 (BRAND NAME), D2A (COMMON DEVICE NAME) AND D2B (PROCODE) REFLECT THIS PRODUCT. THE REMAINDER OF THE INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED PENDING COMPLETION, OR UPON RECEIPT OF NEW INFORMATION.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED DEVELOPING AN INFECTION IN THE NOSE AND RIGHT EAR AFTER UNDERGOING A NASAL SWAB (ABBOTT SWAB) TEST PERFORMED BY A DOCTOR SEVERAL YEARS AGO FOR COVID-19 SCREENING USING AN UNSPECIFIED ABBOTT SWAB PRODUCT ON AN UNKNOWN DATE. THE CONSUMER STATED THAT NASAL AND EAR IRRITATION BEGAN THE DAY AFTER THE SWAB TEST AND WAS PARTICULARLY NOTICEABLE DURING COLD WEATHER. THE CONSUMER CONFIRMED THEY WERE ASYMPTOMATIC FOR COVID-19 AT THE TIME OF TESTING. THE CONSUMER REPORTED RECEIVING A SPRAY-TYPE ANTIBIOTIC PRESCRIBED BY THE DOCTOR AND CONFIRMED THAT NO FOLLOW-UP VISITS WERE REQUIRED AFTER THE INITIAL PRESCRIPTION.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED DEVELOPING AN INFECTION IN THE NOSE AND RIGHT EAR AFTER UNDERGOING A NASAL SWAB (ABBOTT SWAB) TEST PERFORMED BY A DOCTOR SEVERAL YEARS AGO FOR COVID-19 SCREENING USING AN UNSPECIFIED ABBOTT SWAB PRODUCT ON AN UNKNOWN DATE. THE CONSUMER STATED THAT NASAL AND EAR IRRITATION BEGAN THE DAY AFTER THE SWAB TEST AND WAS PARTICULARLY NOTICEABLE DURING COLD WEATHER. THE CONSUMER CONFIRMED THEY WERE ASYMPTOMATIC FOR COVID-19 AT THE TIME OF TESTING. THE CONSUMER REPORTED RECEIVING A SPRAY-TYPE ANTIBIOTIC PRESCRIBED BY THE DOCTOR AND CONFIRMED THAT NO FOLLOW-UP VISITS WERE REQUIRED AFTER THE INITIAL PRESCRIPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2812405 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QYT ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention