BinaxNOW COVID-19 Antigen Self Test 195-160Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,834 adverse event reports that list this exact device (DI 00811877011408), received between May 24, 2021 and May 14, 2026 — classified as 1 death, 111 injuries, 1,722 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (927 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,834 reports, 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 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 ↗
• MalfunctionDec 12, 2025False Negative Result; False Negative Result

  THE CONSUMER REPORTED OBTAINING A FALSE NEGATIVE RESULT USING THE BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2025. INITIAL TESTING WAS PERFORMED AT DOCTOR¿S OFFICE USING UNKNOWN BRAND OF TEST ON (B)(6) 2025 WHICH YIELDED POSITIVE RESULT. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT AND OUTCOME WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23789784 ↗
• MalfunctionDec 9, 2025False Negative Result; False Negative Result

  THE CONSUMER REPORTED A FALSE NEGATIVE TEST RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON (B)(6) 2025. THE CONSUMER REPORTED EXPERIENCING THE SAME SYMPTOMS AS THE PREVIOUS TIME THEY HAD COVID-19. NO ADDITIONAL INFORMATION, INCLUDING TYPE OF SYMPTOMS, TREATMENT, OR OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760088 ↗
• MalfunctionDec 4, 2025False Negative Result; False Negative Result

  THE CONSUMER REPORTED RECEIVING A FALSE NEGATIVE RESULT FROM THE BINAXNOW COVID-19 AG SELF TEST CONDUCTED ON 20NOV2025. THE CONSUMER STATED THEY WERE SYMPTOMATIC, EXPERIENCING LOSS OF TASTE, NAUSEA, VOMITING, AND COUGH. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT AND OUTCOME WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720550 ↗
• MalfunctionDec 3, 2025False Negative Result; False Negative Result

  THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON AN UNKNOWN DATE. THE CONSUMER REPORTED HAVING BEEN SYMPTOMATIC WITH LOSS OF TASTE AND A POSSIBLE SINUS INFECTION. NO ADDITIONAL TESTING WAS PERFORMED, AND NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708554 ↗
• MalfunctionNov 24, 2025False Negative Result; False Negative Result

  THE CONSUMER REPORTED RECEIVING A FALSE NEGATIVE RESULT USING THE BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2025. INITIAL TESTING WAS CONDUCTED ON (B)(6) 2025 AND (B)(6) 2025 USING INTELLSWAB RAPID TESTS, BOTH YIELDING NEGATIVE RESULTS. TWO ADDITIONAL TESTS WERE PERFORMED USING INTELLSWAB RAPID TESTS ON (B)(6) 2025, BOTH OF WHICH PRODUCED POSITIVE RESULTS. CONFIRMATION TESTING WAS PERFORMED ON AN UNKNOWN DATE WITH UNKNOWN TEST BRAND WHICH GENERATED NEGATIVE RESULT. THE CONSUMER REPORTED EXPERIENCING SYMPTOMS INCLUDING BODY ACHES, RUNNY NOSE, AND COUGH AT THE TIME OF TESTING. THE CONSUMER INDICATED INITIATING PAXLOVID TREATMENT ON (B)(6) 2025, CONTINUING THROUGH (B)(6) 2025. THE CONSUMER CONFIRMED THAT THEY ARE NOW FEELING BETTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23634626 ↗
• MalfunctionNov 24, 2025False Negative Result; False Negative Result

  THE CONSUMER REPORTED OBTAINING A FALSE NEGATIVE RESULT USING THE BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2025. ADDITIONAL TESTING WAS PERFORMED TWICE ON THE SAME DAY ((B)(6) 2025) AND ONCE ON THE FOLLOWING DAY ((B)(6) 2025) USING SPEEDYSWAB RAPID TESTS, ALL OF WHICH PRODUCED POSITIVE RESULTS. THE CUSTOMER REPORTED EXPERIENCING TIREDNESS AS THE ONLY SYMPTOM. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632932 ↗
• MalfunctionNov 13, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON (B)(6) 2025. NO ALTERNATIVE TEST WAS TAKEN, BUT THE CUSTOMER MENTIONED SYMPTOMS OF COUGH, SORE THROAT, CHILLS, FEVER, AND LOSS SENSE OF SMELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23548282 ↗
• MalfunctionNov 6, 2025Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Improper or Incorrect Procedure or Method; No Apparent Adverse Event

  THE CONSUMER REPORTED REAGENT EXPOSURE IN HER NOSE WITH THE EXPIRED BINAXNOW COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2025. THE CONSUMER ADDED 6 DROPS OF REAGENT SOLUTION AND INSERTED THE SWAB TO THE BOTTOM HOLE OF THE TEST CARD WITHOUT SWABBING THEIR NOSE. ON REALIZATION THE CONSUMER REMOVED THE SWAB WITH REAGENT SOLUTION AND SWABBED HER NOSE WITH IT. THE CONSUMER WAS ADVISED TO RINSE HER NOSE WITH WATER. THE CONSUMER CONFIRMED THERE WAS NO MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490944 ↗
• MalfunctionOct 20, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON (B)(6) 2025. A TELEHEALTH VISIT WAS COMPLETED AFTER TESTING AND THE DOCTOR DIAGNOSED THE CUSTOMER WITH A COLD. NO COVID-19 DIAGNOSIS WAS GIVEN. THE DOCTOR ADVISED THAT NO FURTHER TESTING OR TREATMENT WAS NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335254 ↗
• MalfunctionOct 15, 2025False Negative Result; False Negative Result

  THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON (B)(6) 2025. ADDITIONAL TESTING WAS PERFORMED EARLIER THE SAME DAY AT A CLINIC (PLATFORM UNKNOWN) AND GENERATED POSITIVE RESULTS. THE CONSUMER REPORTED BEING ASYMPTOMATIC AT THE TIME OF TESTING. NO ADDITIONAL INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278672 ↗
• MalfunctionOct 3, 2025False Negative Result; False Negative Result

  THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2025 WITH A NASAL SAMPLE. REPEAT TESTING WAS PERFORMED AND GENERATED A POSITIVE RESULT. ADDITIONAL TESTING WAS PERFORMED (BRAND UNKNOWN) ON THE SAME DAY, GENERATING POSITIVE RESULTS. THE CONSUMER STATED THAT THEY WERE SYMPTOMATIC AND EXPERIENCING FEVER, SORE THROAT, HEADACHE, AND A RUNNY NOSE. NO ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT AND OUTCOME WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23214143 ↗
• MalfunctionOct 2, 2025False Negative Result; False Negative Result

  THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON (B)(6) 2025 WITH A NASAL SAMPLE. THE CONSUMER RECEIVED A NEGATIVE RESULT ON (B)(6) 2025, ON THE BINAXNOW COVID-19 AG SELF TEST, AND A POSITIVE RESULT ON A DIFFERENT TEST, LATERAL FLOW (UNKNOWN BRAND) ON (B)(6) 2025. ON (B)(6) 2025, THE CUSTOMER TESTED POSITIVE WITH THE BINAXNOW COVID-19 AG SELF-TEST. THE CUSTOMER EXPERIENCES A SORE THROAT AND FEVER. ALTHOUGH REQUESTED, NO ADDITIONAL CONSUMER INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23205851 ↗