BinaxNOW COVID-19 Antigen Self Test 195-170Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00811877011118), received between Dec 18, 2023 and Jan 14, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (12 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2025False Negative Result; False Negative Result

  THE CONSUMER REPORTED SEVEN (7) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON DIFFERENT DATES. THIS MFR. REPORT ADDRESSES TEST SEVEN (7) OF SEVEN (7). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON UNKNOWN DATE WITH UNKNOWN SAMPLE TYPE. IN THE WEEK PRIOR (DATE UNKNOWN) TO THE NEGATIVE RESULT, THE CONSUMER TESTED POSITIVE USING ACCESS BIO AND ROCHE TEST WITH UNKNOWN SAMPLE TYPE. THE CONSUMER REPORTED BEING SYMPTOMATIC. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT AND OUTCOME WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21154334 ↗
• MalfunctionJan 14, 2025False Negative Result; False Negative Result

  THE CONSUMER REPORTED SEVEN (7) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON DIFFERENT DATES. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF SEVEN (7). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON (B)(6) 2024 WITH UNKNOWN SAMPLE TYPE. IN THE WEEK PRIOR (DATE UNKNOWN) TO THE NEGATIVE RESULT, THE CONSUMER TESTED POSITIVE USING ACCESS BIO AND ROCHE TEST WITH UNKNOWN SAMPLE TYPE. THE CONSUMER REPORTED BEING SYMPTOMATIC. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT AND OUTCOME WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21154330 ↗
• MalfunctionJan 14, 2025False Negative Result; False Negative Result

  THE CONSUMER REPORTED SEVEN (7) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON DIFFERENT DATES. THIS MFR. REPORT ADDRESSES TEST THREE (3) OF SEVEN (7). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON UNKNOWN DATE WITH UNKNOWN SAMPLE TYPE. IN THE WEEK PRIOR (DATE UNKNOWN) TO THE NEGATIVE RESULT, THE CONSUMER TESTED POSITIVE USING ACCESS BIO AND ROCHE TEST WITH UNKNOWN SAMPLE TYPE. THE CONSUMER REPORTED BEING SYMPTOMATIC. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT AND OUTCOME WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21154328 ↗
• MalfunctionJan 14, 2025False Negative Result; False Negative Result

  THE CONSUMER REPORTED SEVEN (7) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON DIFFERENT DATES. THIS MFR. REPORT ADDRESSES TEST SIX (6) OF SEVEN (7). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON UNKNOWN DATE WITH UNKNOWN SAMPLE TYPE. IN THE WEEK PRIOR (DATE UNKNOWN) TO THE NEGATIVE RESULT, THE CONSUMER TESTED POSITIVE USING ACCESS BIO AND ROCHE TEST WITH UNKNOWN SAMPLE TYPE. THE CONSUMER REPORTED BEING SYMPTOMATIC. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT AND OUTCOME WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21154327 ↗
• MalfunctionJan 14, 2025False Negative Result; False Negative Result

  THE CONSUMER REPORTED SEVEN (7) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON DIFFERENT DATES. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF SEVEN (7). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON UNKNOWN DATE WITH UNKNOWN SAMPLE TYPE. IN THE WEEK PRIOR (DATE UNKNOWN) TO THE NEGATIVE RESULT, THE CONSUMER TESTED POSITIVE USING ACCESS BIO AND ROCHE TEST WITH UNKNOWN SAMPLE TYPE. THE CONSUMER REPORTED BEING SYMPTOMATIC. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT AND OUTCOME WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21154326 ↗
• MalfunctionJan 14, 2025False Negative Result; False Negative Result

  THE CONSUMER REPORTED SEVEN (7) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON DIFFERENT DATES. THIS MFR. REPORT ADDRESSES TEST FIVE (5) OF SEVEN (7). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON UNKNOWN DATE WITH UNKNOWN SAMPLE TYPE. IN THE WEEK PRIOR (DATE UNKNOWN) TO THE NEGATIVE RESULT, THE CONSUMER TESTED POSITIVE USING ACCESS BIO AND ROCHE TEST WITH UNKNOWN SAMPLE TYPE. THE CONSUMER REPORTED BEING SYMPTOMATIC. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT AND OUTCOME WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21154325 ↗
• MalfunctionJan 14, 2025False Negative Result; False Negative Result

  THE CONSUMER REPORTED SEVEN (7) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON DIFFERENT DATES. THIS MFR. REPORT ADDRESSES TEST FOUR (4) OF SEVEN (7). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON UNKNOWN DATE WITH UNKNOWN SAMPLE TYPE. IN THE WEEK PRIOR (DATE UNKNOWN) TO THE NEGATIVE RESULT, THE CONSUMER TESTED POSITIVE USING ACCESS BIO AND ROCHE TEST WITH UNKNOWN SAMPLE TYPE. THE CONSUMER REPORTED BEING SYMPTOMATIC. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT AND OUTCOME WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21154324 ↗
• MalfunctionOct 7, 2024False Positive Result; False Positive Result

  THE CONSUMER REPORTED MULTIPLE FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON VARIOUS DATES. THIS MFR. REPORT IS ONE (1) OF 4 (FOUR). THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON OR BEFORE (B)(6) 2024 WITH UNKNOWN SAMPLE TYPE. CONFIRMATORY TESTING WAS PERFORMED USING PCR TEST WITH UNKNOW SAMPLE TYPE ON 28AUG2024 WHICH GAVE NEGATIVE RESULT. THE CONSUMER CONFIRMED THAT SHE WAS ASYMPTOMATIC AND NO PATIENT HARM DUE TO THE TEST RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20390511 ↗
• MalfunctionOct 7, 2024False Positive Result; False Positive Result

  THE CONSUMER REPORTED MULTIPLE FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON VARIOUS DATES. THIS MFR. REPORT IS TWO (2) OF 4 (FOUR). THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON OR WITHIN THE WEEK OF (B)(6) 2024 WITH UNKNOWN SAMPLE TYPE. CONFIRMATORY TESTING WAS PERFORMED USING PCR TEST WITH UNKNOW SAMPLE TYPE ON (B)(6) 2024 WHICH GAVE NEGATIVE RESULT. THE CONSUMER CONFIRMED THAT SHE WAS ASYMPTOMATIC AND NO PATIENT HARM DUE TO THE TEST RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20389137 ↗
• MalfunctionOct 7, 2024False Positive Result; False Positive Result

  THE CONSUMER REPORTED MULTIPLE FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON VARIOUS DATES. THIS MFR. REPORT IS FOUR (4) OF 4 (FOUR). THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON (B)(6) 2024 WITH NASAL SAMPLE TYPE. ADDITIONAL TESTING WAS PERFORMED USING FLOW FLEX TEST WITH UNKNOW SAMPLE TYPE ON (B)(6) 2024 WHICH GAVE NEGATIVE RESULT. THE CONSUMER CONFIRMED THAT SHE WAS ASYMPTOMATIC AND NO PATIENT HARM DUE TO THE TEST RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20388113 ↗
• MalfunctionOct 7, 2024False Positive Result; False Positive Result

  THE CONSUMER REPORTED MULTIPLE FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON VARIOUS DATES. THIS MFR. REPORT IS THREE (3) OF 4 (FOUR). THE CONSUMER REPORTED AN UNKNOW QUANTITY OF FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED BETWEEN THE DATES (B)(6) 2024 WITH UNKNOWN SAMPLE TYPE. CONFIRMATORY TESTING WAS PERFORMED USING PCR TEST WITH UNKNOW SAMPLE TYPE ON (B)(6) 2024 WHICH GAVE NEGATIVE RESULT. ADDITIONAL TESTING WAS PERFORMED USING FLOW FLEX TEST WITH UNKNOW SAMPLE TYPE ON (B)(6) 2024 WHICH GAVE NEGATIVE RESULT. THE CONSUMER CONFIRMED THAT SHE WAS ASYMPTOMATIC AND NO PATIENT HARM DUE TO THE TEST RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20387779 ↗
• MalfunctionAug 22, 2024False Negative Result; False Negative Result

  THE CONSUMER REPORTED FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST KIT FOR FIVE (5) TESTS PERFORMED ON OR BEFORE (B)(6) 2024. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF FIVE (5). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON OR BEFORE (B)(6) 2024 ON A NASAL SAMPLE. REPEAT TESTING WAS PERFORMED ON THE SAME DAY WHICH GENERATED A POSITIVE RESULT. NO ADDITIONAL INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20030535 ↗
• MalfunctionAug 20, 2024False Negative Result; False Negative Result

  THE CONSUMER REPORTED FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST KIT FOR FIVE (5) TESTS PERFORMED ON OR BEFORE (B)(6) 2024. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF FIVE (5). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON OR BEFORE (B)(6) 2024 ON A NASAL SAMPLE. REPEAT TESTING WAS PERFORMED ON THE SAME DAY WHICH GENERATED A POSITIVE RESULT. NO ADDITIONAL INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20007765 ↗
• MalfunctionAug 20, 2024False Negative Result; False Negative Result

  THE CONSUMER REPORTED FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST KIT FOR FIVE (5) TESTS PERFORMED ON OR BEFORE (B)(6) 2024. THIS MFR. REPORT ADDRESSES TEST FIVE (5) OF FIVE (5). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON OR BEFORE (B)(6) 2024 ON A NASAL SAMPLE. REPEAT TESTING WAS PERFORMED ON THE SAME DAY WHICH GENERATED A POSITIVE RESULT. NO ADDITIONAL INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20002797 ↗
• MalfunctionAug 20, 2024False Negative Result; False Negative Result

  THE CONSUMER REPORTED FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST KIT FOR FIVE (5) TESTS PERFORMED ON OR BEFORE (B)(6) 2024. THIS MFR. REPORT ADDRESSES TEST FOUR (4) OF FIVE (5). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON OR BEFORE (B)(6) 2024 ON A NASAL SAMPLE. REPEAT TESTING WAS PERFORMED ON THE SAME DAY WHICH GENERATED A POSITIVE RESULT. NO ADDITIONAL INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20000803 ↗
• MalfunctionAug 20, 2024False Negative Result; False Negative Result

  THE CONSUMER REPORTED FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST KIT FOR FIVE (5) TESTS PERFORMED ON OR BEFORE (B)(6) 2024. THIS MFR. REPORT ADDRESSES TEST THREE (3) OF FIVE (5). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON OR BEFORE (B)(6) 2024 ON A NASAL SAMPLE. REPEAT TESTING WAS PERFORMED ON THE SAME DAY WHICH GENERATED A POSITIVE RESULT. NO ADDITIONAL INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20000605 ↗
• MalfunctionJan 29, 2024False Positive Result; False Positive Result

  THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2024 ON A NASAL SAMPLE. REPEAT TESTING WAS PERFORMED TWICE ON THE SAME DAY WHICH GENERATED NEGATIVE RESULTS. CONFIRMATION TESTING WAS PERFORMED ON THE SAME DAY VIA PCR (PLATFORM: UNKNOWN) WHICH GENERATED A NEGATIVE RESULT. THE CONSUMER INDICATED THEY WERE ASYMPTOMATIC. THE CONSUMER CONFIRMED THERE WAS NO HARM 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 18603003 ↗
• MalfunctionJan 12, 2024False Positive Result; False Positive Result

  THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023 ON AN UNKNOWN SAMPLE TYPE. REPEAT TESTING WAS PERFORMED THREE (3) TIMES ON THE SAME DAY, EACH GENERATING A NEGATIVE RESULT. THREE (3) ADDITIONAL TESTS WERE PERFORMED ON THE SAME DAY USING AN INTELISWAB RAPID ANTIGEN TEST, AN ACCESS BIO RAPID ANTIGEN TEST, AND A LUCIRA RAPID ANTIGEN TEST, ALL GENERATING NEGATING RESULTS. NO ADDITIONAL INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18507942 ↗
• MalfunctionDec 18, 2023Non Reproducible Results; Non Reproducible Results

  THE CONSUMER REPORTED CONFLICTING RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST KIT PERFORMED ON AN UNKNOWN DATE. THE FIRST TEST TAKEN GENERATED A POSITIVE RESULT, AND THE SECOND TEST, PERFORMED ON THE SAME DAY, GENERATED A NEGATIVE RESULT. INITIAL TESTING WAS PERFORMED THREE (3) TIMES USING THE BINAXNOW COVID-19 ANTIGEN SELF-TEST KIT, GENERATING NEGATIVE RESULTS. IT IS UNCLEAR IF ADDITIONAL TESTING WAS PERFORMED. NO ADDITIONAL INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18352373 ↗