BinaxNOW COVID-19 Antigen Self Test 195-140Recalls & reported problems
Alere Scarborough, Inc. · A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens. · Class 2
All models of BinaxNOW COVID-19 Antigen Self Test (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00811877011477), received between May 28, 2024 and Nov 6, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (3 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- False Negative Result3
- False Positive Result1
- Non Reproducible Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 2024False Positive Result; False Positive Result
THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON (B)(6) 2024. THE CONSUMER TOOK TWO TESTS FROM DIFFERENT BRANDS ON (B)(6) 2024 (FLOWFLEX AND IHEALTH), BOTH OF WHICH RETURNED NEGATIVE RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT AND OUTCOME WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20616653 ↗MalfunctionAug 22, 2024Non Reproducible Results; Non Reproducible Results
THE CONSUMER REPORTED CONFLICTING RESULTS WITH TWO (2) BINAXNOW COVID-19 AG SELF TESTS, BOTH PERFORMED ON (B)(6) 2024. BOTH TESTS WERE FROM LOT 809122C. THE CONSUMER RECEIVED A POSITIVE RESULT FOR HER FIRST TEST, AND A NEGATIVE RESULT FOR HER SECOND TEST. NO CONFIRMATORY TEST INFORMATION WAS PROVIDED TO DETERMINE WHICH TEST RESULT WAS CORRECT. NO OTHER INFORMATION, INCLUDING CONSUMER INFORMATION, IMPACT TO PATIENT, OR TREATMENT, WAS PROVIDED. ADDITIONAL INFORMATION WAS UNABLE TO BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20042930 ↗MalfunctionAug 22, 2024False Negative Result; False Negative Result
THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2024. ADDITIONAL TESTING WAS PERFORMED ON 2024 (B)(6) WITH A FLOWFLEX ANTIGEN SELF-TEST AND GENERATED A POSITIVE RESULT. THE CONSUMER WAS SYMPTOMATIC. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20039217 ↗MalfunctionJul 21, 2024False Negative Result; False Negative Result
THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2024. ADDITIONAL TESTING WAS PERFORMED ON 21JUN2024 WITH AN UNKNOWN BRAND AND GENERATED A POSITIVE RESULT. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT, WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19788665 ↗MalfunctionMay 28, 2024False Negative Result; False Negative Result
THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2024. ADDITIONAL TESTING WAS PERFORMED ON AN UNKNOWN DATE WITH AN UNKNOWN TEST (PLATFORM - UNKNOWN) WHICH GENERATED A POSITIVE RESULT. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19411002 ↗
Other Over-The-Counter Covid-19 Antigen Test devices
- BinaxNOW COVID-19 Antigen Self Test 195-160Alere Scarborough, Inc. · Over-The-Counter Covid-19 Antigen Test1 death1,834 reports
- BinaxNOW COVID-19 Antigen Self Test 195-180Alere Scarborough, Inc. · Over-The-Counter Covid-19 Antigen Test27 reports
- BinaxNOW COVID-19 Antigen Self Test 195-170Alere Scarborough, Inc. · Over-The-Counter Covid-19 Antigen Test19 reports
- CVS Health At Home COVID-19 Test Kit 20452Diagnostic Hybrids, Inc. · Over-the-Counter COVID-19 Antigen Test16 reports
- Flowflex COVID-19 Antigen Home Test L031-118B5, L031-125M5, L031-125N5, L031-125P5Acon Laboratories, Inc. · Over-the-Counter COVID-19 Antigen Test14 reports
- iHealth ICO-3000iHealth Labs Inc. · Over-The-Counter Covid-19 Antigen Test5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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