FDA Adverse Event Malfunction Summary report: N

BINAXNOW COVID-19 AG SELF TEST 2CT

MDR report key: 23193837 · Received October 1, 2025

Report

Report Number: 1221359-2025-00406
Event Type: Malfunction
Date Received: October 1, 2025
Date of Event: January 1, 2025
Report Date: October 1, 2025
Manufacturer: ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
Product Code: QYT
PMA / PMN Number: K243518
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

B3 (DATE OF EVENT): THE DATE LISTED IS AN ESTIMATED DATE, AS THE CONSUMER DID NOT PROVIDE THE ACTUAL DATE OF THE EVENT. 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. NOTWITHSTANDING, COMPLAINTS AGAINST THESE TREND CODES ARE MONITORED TO IDENTIFY AND TRACK ANY OUT-OF-TREND/UNEXPECTED PERFORMANCE AT THE LOT AND PRODUCT FAMILY LEVEL. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUES AS NO INFORMATION WAS PROVIDED FOR INVESTIGATION. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.

Description of Event or Problem · 0

THE CONSUMER REPORTED TWO (2) FALSE NEGATIVE RESULTS VIA SOCIAL MEDIA WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON AN UNKNOWN DATE. THIS REPORT IS FOR TEST ONE (1) OF TWO (2). THE CONSUMER INDICATED THAT THEY RECEIVED FALSE NEGATIVE RESULTS ON THE BINAXNOW COVID-19 ANTIGEN SELF-TEST. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2014687	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