BinaxNOW COVID-19 Antigen Self TestRecalls & reported problems across all models
Alere Scarborough, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,899
- Deaths reported
- 1
- Injuries reported
- 113
- Recalls
- 0
We found 5 models of BinaxNOW COVID-19 Antigen Self Test by Alere Scarborough, Inc. in the FDA's device registry (GUDID). Together they are named in 1,899 adverse event reports in the FDA's MAUDE database, received between May 24, 2021 and May 14, 2026 — classified as 1 death, 113 injuries, 1,785 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (967 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported BinaxNOW COVID-19 Antigen Self Test problems
Device problems
- False Negative Result967
- False Positive Result478
- Non Reproducible Results242
- Use of Device Problem90
- Improper or Incorrect Procedure or Method87
- No Apparent Adverse Event45
- Adverse Event Without Identified Device or Use Problem7
- Component Missing5
Patient problems
- No Clinical Signs, Symptoms or Conditions1,747
- Insufficient Information94
- Burning Sensation15
- Eye Pain14
- Red Eye(s)9
- Eye Irritation5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Headache4
BinaxNOW COVID-19 Antigen Self Test models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BinaxNOW COVID-19 Antigen Self Test 195-160Over-The-Counter Covid-19 Antigen Test1 death1,834 reports
- BinaxNOW COVID-19 Antigen Self Test 195-180Over-The-Counter Covid-19 Antigen Test27 reports
- BinaxNOW COVID-19 Antigen Self Test 195-170Over-The-Counter Covid-19 Antigen Test19 reports
- BinaxNOW COVID-19 Antigen Self Test 195-260Coronavirus Antigen Detection Test System.14 reports
- BinaxNOW COVID-19 Antigen Self Test 195-140Over-The-Counter Covid-19 Antigen Test5 reports
Recent BinaxNOW COVID-19 Antigen Self Test adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2026False Negative Result
THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST TAKEN ON (B)(6) 2026. NO CONFIRMATORY TEST WAS TAKEN AS THE CONSUMER DID NOT WANT TO SEEK CONSULTATION WITH A HEALTHCARE PROVIDER. THE CONSUMER EXPERIENCED LOSS OF TASTE, COLD, HEADACHE, AND A SORE THROAT AT THE TIME OF TESTING. NO NEGATIVE PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25178216 ↗MalfunctionMay 1, 2026False Positive Result
THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 SELF-TEST ON AN UNKNOWN DATE ON (B)(6) 2025. THE CONSUMER INDICATED THAT THE RESULT SHOWED A DARK PINK CONTROL LINE AND A FAINT PINK SAMPLE LINE (INDICATES A POSITIVE RESULT) AND WAS UNSURE IF THE RESULT WAS POSITIVE. DUE TO WHAT THE CONSUMER REPORTED AS AN INCONCLUSIVE RESULT, THEY VISITED AN URGENT CARE CENTER WHERE AN UNKNOWN COVID-19 RAPID TEST WAS PERFORMED THAT PRESENTED A NEGATIVE RESULT. THE CONSUMER REPORTED TO HAVE BEEN SYMPTOMATIC INCLUDING A MILD SORE THROAT. NO NEGATIVE IMPACT WAS REPORTED AS A RESULT. NO FURTHER INFORMATION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25056988 ↗MalfunctionApr 20, 2026False Negative Result
THE CONSUMER REPORTED FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST KIT FOR TWO (2) TESTS PERFORMED ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF TWO (2). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2026 ON AN UNKNOWN SAMPLE TYPE. REPEAT TESTING WITH BINAXNOW WAS PERFORMED ON (B)(6) 2026 WHICH GENERATED AN ADDITIONAL NEGATIVE RESULT. ADDITIONAL TESTING WAS PERFORMED AT A WALK-IN CLINIC ON (B)(6) 2026 USING AN UNKNOWN TESTING METHOD WHICH GENERATED A POSITIVE RESULT. THE CONSUMER INDICATED THEY WERE EXPERIENCING SYMPTOMS SUCH AS NAUSEA AND CONGESTION. THE CONSUMER CONFIRMED THERE WAS NO INJURY DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24927773 ↗MalfunctionApr 20, 2026False Negative Result
THE CONSUMER REPORTED FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST KIT FOR TWO (2) TESTS PERFORMED ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF TWO (2). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 20264 ON AN UNKNOWN SAMPLE TYPE. INITIAL TESTING WITH BINAXNOW WAS PERFORMED ON (B)(6) 2026 WHICH GENERATED A NEGATIVE RESULT. ADDITIONAL TESTING WAS PERFORMED AT A WALK-IN CLINIC ON (B)(6) 2026 USING AN UNKNOWN TESTING METHOD WHICH GENERATED A POSITIVE RESULT. THE CONSUMER INDICATED THEY WERE EXPERIENCING SYMPTOMS SUCH AS NAUSEA AND CONGESTION. THE CONSUMER CONFIRMED THERE WAS NO INJURY DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24927690 ↗MalfunctionMar 31, 2026False Negative Result
THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON (B)(6) 2026. THE CONSUMER VISITED AN URGENT CARE CENTER ON (B)(6) 2026 AND RECEIVED A POSITIVE RESULT WITH AN UNKNOWN TEST METHOD. THE CONSUMER REPORTED HAVING NO SYMPTOMS BUT EXPRESSED UNCERTAINTY DETERMINING WHICH RESULT WAS CORRECT. NO OTHER IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24746055 ↗MalfunctionMar 25, 2026False Negative Result
THE CONSUMER REPORTED RECEIVING A FALSE NEGATIVE RESULT FROM THE BINAXNOW COVID-19 AG SELF TEST CONDUCTED ON (B)(6) 2026. THE CONSUMER STATED THEY WERE SYMPTOMATIC AT THE TIME OF TESTING, EXPERIENCING LOSS OF SMELL. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING CONFIRMATORY TESTING, PATIENT TREATMENT AND OUTCOME WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688995 ↗MalfunctionMar 23, 2026False Positive Result
THE CONSUMER REPORTED A SINGLE FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON (B)(6) 2026. INITIAL TESTING HAD BEEN PERFORMED ON (B)(6) 2026 USING A POC SARS-COVID-2 AG TEST (BRAND/TYPE UNKNOWN) AT DOCTOR'S OFFICE AND ON (B)(6) 2026 USING BINAXNOW COVID-19 AG SELF TEST AT MEDICAL CLINIC, BOTH TESTS GENERATED NEGATIVE RESULTS. NO INFORMATION REGARDING CONFIRMATORY TESTING WAS PROVIDED. THE CONSUMER REPORTED FEELING TIRED AS THE SYMPTOM PRESENT AT THE TIME OF TESTING. THE CONSUMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24662807 ↗MalfunctionFeb 24, 2026False Negative Result
THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST ON (B)(6) 2026. THE CONSUMER TESTED POSITIVE THE FOLLOWING DAY, (B)(6) 2026, WITH A BINAXNOW¿ COVID-19/FLU A&B COMBO SELF TEST. THE CONSUMER INDICATED THAT THEY WERE SYMPTOMATIC WITH A RUNNY NOSE AND HEADACHE. NO ADDITIONAL INFORMATION RELATED TO PATIENT TREATMENT AND OUTCOME WAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24434641 ↗MalfunctionFeb 18, 2026False Positive Result
THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST TAKEN ON (B)(6) 2026. A TEST OF UNKNOWN BRAND WAS TAKEN ON (B)(6) 2026 AND RETURNED A NEGATIVE RESULT. THE CONSUMER IS EXPERIENCING COUGH, HEADACHE, AND BODY ACHES. NO ADDITIONAL INFORMATION, INCLUDING TREATMENT AND OUTCOME WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24377936 ↗MalfunctionFeb 13, 2026False Negative Result
THE CONSUMER REPORTED RECEIVING A FALSE NEGATIVE RESULT FROM THE BINAXNOW COVID-19 AG SELF TEST CONDUCTED ON (B)(6) 2026. THE CONSUMER STATED THEY WERE SYMPTOMATIC AT THE TIME OF TESTING, EXPERIENCING LOSS OF TASTE, SORE THROAT AND COLD. NO ADDITIONAL TESTING WAS CONDUCTED USING ANOTHER TEST BRAND, AND NO CONFIRMATORY TESTING WAS PERFORMED. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT AND OUTCOME WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24333477 ↗MalfunctionFeb 11, 2026Non Reproducible Results
THE CONSUMER REPORTED CONFLICTING RESULTS WITH THE BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2026. THE CONSUMER REPORTED THAT TWO TESTS WERE TAKEN THE SAME DAY; THE FIRST REST GENERATED A NEGATIVE RESULT WHEREAS THE SECOND TEST GENERATED A POSITIVE RESULT. THE CONSUMER INDICATED THAT THEY WERE SYMPTOMATIC WITH SNEEZING, COUGHING, HEAD AND BODY ACHES AT THE TIME OF THE TESTS. NO FURTHER TESTS WERE TAKEN. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24314724 ↗MalfunctionJan 19, 2026False Positive Result
THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON (B)(6) 2026. THE CUSTOMER WENT TO THEIR HEALTHCARE PROVIDER A FEW DAYS LATER (DATE UNKNOWN) AND RECEIVED A NEGATIVE RESULT WITH A TEST OF UNKNOWN BRAND AND METHOD. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING TREATMENT OR OUTCOME WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24109388 ↗MalfunctionJan 12, 2026False Negative Result
THE CONSUMER REPORTED TWO (2) FALSE NEGATIVE RESULTS OBTAINED WITH THE BINAXNOW COVID 19 AG SELF TESTS PERFORMED ON (B)(6) 2026. THIS MANUFACTURER REPORT ADDRESSES TEST ONE (1) OF THE TWO (2) TESTS ADMINISTERED BY THE USER. THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID 19 AG SELF TEST PERFORMED ON (B)(6) 2026 USING AN UNKNOWN SAMPLE TYPE. THE CONSUMER PREVIOUSLY TESTED WITH A DIFFERENT BRAND OF TEST (BRAND UNKNOWN) ON (B)(6) 2025, WHICH YIELDED A POSITIVE RESULT. NO CONFIRMATION TESTING WAS CONDUCTED. THE CONSUMER REPORTED EXPERIENCING A HEADACHE AS A SYMPTOM. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24046283 ↗MalfunctionJan 12, 2026False Negative Result
THE CONSUMER REPORTED TWO (2) FALSE NEGATIVE RESULTS OBTAINED WITH THE BINAXNOW COVID 19 AG SELF TESTS PERFORMED ON (B)(6) 2026. THIS MANUFACTURER REPORT ADDRESSES TEST TWO (2) OF THE TWO (2) TESTS ADMINISTERED TO THE USER¿S CHILD. THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON THEIR CHILD ON (B)(6) 2026 USING AN UNKNOWN SAMPLE TYPE. THE CHILD HAD PREVIOUSLY BEEN TESTED WITH A DIFFERENT BRAND OF TEST (BRAND UNKNOWN) ON (B)(6) 2025, WHICH YIELDED A POSITIVE RESULT. NO CONFIRMATION TESTING WAS CONDUCTED. THE CONSUMER STATED THAT THEIR CHILD EXPERIENCED SYMPTOMS SUCH AS CONGESTION AND WAS FEELING UNWELL. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24046280 ↗MalfunctionJan 5, 2026Non Reproducible Results
THE CONSUMER REPORTED CONFLICTING RESULTS WITHIN THE READ WINDOW WHEN USING THE BINAXNOW COVID-19 AG SELF TEST ON (B)(6) 2025. AT 16 MINUTES THE TEST READ AS POSITIVE, AND AT 22 MINUTES THE TEST READ AS NEGATIVE. THE READ WINDOW FOR THE TEST IS BETWEEN 15 AND 30 MINUTES. NO ADDITIONAL INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23960325 ↗
Other Alere Scarborough, Inc. products
All Alere Scarborough, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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