BinaxNOW COVID-19 Ag Card 195-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,312 adverse event reports that list this exact device (DI 10811877011290), received between Nov 6, 2020 and May 14, 2026 — classified as 13 injuries, 1,299 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (787 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 1,312 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026False Positive Result

  THE CUSTOMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH TWO (2) PATIENTS WITH THE BINAXNOW COVID-19 AG TEST TAKEN ON (B)(6) 2026. THE REPORT IS FOR TEST 1 WITH PATIENT 2. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG TEST TAKEN ON (B)(6) 2026. A PCR TEST RETURNED NEGATIVE RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING TREATMENT OR OUTCOME WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25178066 ↗
• MalfunctionMay 14, 2026False Positive Result

  THE CUSTOMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH TWO (2) PATIENTS WITH THE BINAXNOW COVID-19 AG TEST TAKEN ON (B)(6) 2026. THE REPORT IS FOR TEST 2 WITH PATIENT 1. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG TEST TAKEN ON (B)(6) 2026. A PCR TEST RETURNED NEGATIVE RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING TREATMENT OR OUTCOME WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25178061 ↗
• MalfunctionMay 14, 2026False Positive Result

  THE CUSTOMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH TWO (2) PATIENTS WITH THE BINAXNOW COVID-19 AG TEST TAKEN ON (B)(6) 2026. THE REPORT IS FOR TEST 1 WITH PATIENT 1. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG TEST TAKEN ON (B)(6) 2026. A PCR TEST RETURNED NEGATIVE RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING TREATMENT OR OUTCOME WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25178059 ↗
• MalfunctionMay 14, 2026False Positive Result

  THE CUSTOMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH TWO (2) PATIENTS WITH THE BINAXNOW COVID-19 AG TEST TAKEN ON (B)(6) 2026. THE REPORT IS FOR TEST 2 WITH PATIENT 2. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG TEST TAKEN ON (B)(6) 2026. A PCR TEST RETURNED NEGATIVE RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING TREATMENT OR OUTCOME WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25178058 ↗
• MalfunctionMar 21, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD KIT PERFORMED ON (B)(6) 2025 ON MULTIPLE PATIENTS. THIS REPORT ADDRESSES PATIENT ONE (1) OF TEN (10). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG CARD KIT PERFORMED ON (B)(6) 2025. NO CONFIRMATORY TEST WAS PERFORMED. ALTHOUGH REQUESTED, INFORMATION REGARDING PATIENT TREATMENT AND OUTCOME WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21668570 ↗
• MalfunctionMar 21, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD KIT PERFORMED ON (B)(6) 2025 ON MULTIPLE PATIENTS. THIS REPORT ADDRESSES PATIENT FIVE (5) OF TEN (10). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG CARD KIT PERFORMED ON (B)(6) 2025. NO CONFIRMATORY TEST WAS PERFORMED. ALTHOUGH REQUESTED, INFORMATION REGARDING PATIENT TREATMENT AND OUTCOME WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21668568 ↗
• MalfunctionMar 21, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD KIT PERFORMED ON (B)(6) 2025 ON MULTIPLE PATIENTS. THIS REPORT ADDRESSES PATIENT EIGHT (8) OF TEN (10). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG CARD KIT PERFORMED ON (B)(6) 2025. NO CONFIRMATORY TEST WAS PERFORMED. ALTHOUGH REQUESTED, INFORMATION REGARDING PATIENT TREATMENT AND OUTCOME WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21668565 ↗
• MalfunctionMar 21, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD KIT PERFORMED ON (B)(6) 2025 ON MULTIPLE PATIENTS. THIS REPORT ADDRESSES PATIENT SEVEN (7) OF TEN (10). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG CARD KIT PERFORMED ON (B)(6) 2025. NO CONFIRMATORY TEST WAS PERFORMED. ALTHOUGH REQUESTED, INFORMATION REGARDING PATIENT TREATMENT AND OUTCOME WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21668564 ↗
• MalfunctionMar 21, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD KIT PERFORMED ON (B)(6) 2025 ON MULTIPLE PATIENTS. THIS REPORT ADDRESSES PATIENT FOUR (4) OF TEN (10). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG CARD KIT PERFORMED ON (B)(6) 2025. NO CONFIRMATORY TEST WAS PERFORMED. ALTHOUGH REQUESTED, INFORMATION REGARDING PATIENT TREATMENT AND OUTCOME WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21668562 ↗
• MalfunctionMar 21, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD KIT PERFORMED ON (B)(6) 2025 ON MULTIPLE PATIENTS. THIS REPORT ADDRESSES PATIENT THREE (3) OF TEN (10). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG CARD KIT PERFORMED ON (B)(6) 2025. NO CONFIRMATORY TEST WAS PERFORMED. ALTHOUGH REQUESTED, INFORMATION REGARDING PATIENT TREATMENT AND OUTCOME WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21668561 ↗
• MalfunctionMar 21, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD KIT PERFORMED ON (B)(6) 2025 ON MULTIPLE PATIENTS. THIS REPORT ADDRESSES PATIENT TEN (10) OF TEN (10). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG CARD KIT PERFORMED ON (B)(6) 2025. THE PATIENT RETURNED TWO DAYS LATER TO TEST WITH ANOTHER BINAXNOW COVID-19 AG CARD TEST, WHICH RETURNED A NEGATIVE RESULT. ALTHOUGH REQUESTED, INFORMATION REGARDING PATIENT TREATMENT AND OUTCOME WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21668560 ↗
• MalfunctionMar 21, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD KIT PERFORMED ON (B)(6) 2025 ON MULTIPLE PATIENTS. THIS REPORT ADDRESSES PATIENT NINE (9) OF TEN (10). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG CARD KIT PERFORMED ON (B)(6) 2025. NO CONFIRMATORY TEST WAS PERFORMED. ALTHOUGH REQUESTED, INFORMATION REGARDING PATIENT TREATMENT AND OUTCOME WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21668559 ↗
• MalfunctionMar 21, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD KIT PERFORMED ON (B)(6) 2025 ON MULTIPLE PATIENTS. THIS REPORT ADDRESSES PATIENT TWO (2) OF TEN (10). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG CARD KIT PERFORMED ON (B)(6) 2025. NO CONFIRMATORY TEST WAS PERFORMED. ALTHOUGH REQUESTED, INFORMATION REGARDING PATIENT TREATMENT AND OUTCOME WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21668556 ↗
• MalfunctionMar 21, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD KIT PERFORMED ON (B)(6) 2025 ON MULTIPLE PATIENTS. THIS REPORT ADDRESSES PATIENT SIX (6) OF TEN (10). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG CARD KIT PERFORMED ON (B)(6) 2025. NO CONFIRMATORY TEST WAS PERFORMED. ALTHOUGH REQUESTED, INFORMATION REGARDING PATIENT TREATMENT AND OUTCOME WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21668552 ↗
• MalfunctionNov 21, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED THREE (3) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG TEST PERFORMED ON VARIOUS DATES WITH THE SAME PATIENT. THIS REPORT IS FOR TEST TWO (2) OF THREE (3). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG TEST PERFORMED ON AN UNKNOWN DATE. A PCR TEST WAS SENT TO AN OUTSIDE LAB (DATE UNKNOWN) WHERE THE RESULT WAS NEGATIVE. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20747029 ↗
• MalfunctionNov 21, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED THREE (3) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG TEST PERFORMED ON VARIOUS DATES WITH THE SAME PATIENT. THIS REPORT IS FOR TEST THREE (3) OF THREE (3). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG TEST PERFORMED ON AN UNKNOWN DATE. A PCR TEST WAS SENT TO AN OUTSIDE LAB (DATE UNKNOWN) WHERE THE RESULT WAS NEGATIVE. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20747000 ↗
• MalfunctionOct 3, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG TEST PERFORMED ON (B)(6) 2024. THE CUSTOMER TESTED A PATIENT WITH MORE THAN TWO (2) OTHER ANTIGEN TESTS (BRANDS AND DATES TESTED UNKNOWN), ALL OF WHICH RETURNED A NEGATIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20361043 ↗
• MalfunctionJul 16, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED TWO FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD PERFORMED ON (B)(6) 2024 AND (B)(6) 2024 ON A NASAL SAMPLE. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF TWO (2). CONFIRMATION PCR (PLATFORM - UNKNOWN) TESTING WAS PERFORMED ON THE FOLLOWING DAY WHICH GENERATED A NEGATIVE RESULT. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC AND REVIEWED FOR CROSS REACTIVITY. THE CUSTOMER STATED THAT THE PATIENT IS NOT ON ANY INTERFERING SUBSTANCES. PATIENTS WERE TRANSFERRED TO A QUARANTINE AREA DUE TO FALSE POSITIVE RESULT. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19754841 ↗
• MalfunctionJul 16, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED TWO FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD PERFORMED ON (B)(6) 2024 ON A NASAL SAMPLE. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF TWO (2). CONFIRMATION PCR (PLATFORM - UNKNOWN) TESTING WAS PERFORMED ON THE FOLLOWING DAY WHICH GENERATED A NEGATIVE RESULT. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC AND REVIEWED FOR CROSS REACTIVITY. THE CUSTOMER STATED THAT THE PATIENT IS NOT ON ANY INTERFERING SUBSTANCES. PATIENTS WERE TRANSFERRED TO A QUARANTINE AREA DUE TO FALSE POSITIVE RESULT. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19754822 ↗
• MalfunctionJun 28, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED AN UNKNOWN NUMBER OF FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON UNKNOWN DATES. THE SAMPLE AND SWAB TYPES WERE NOT PROVIDED. THIS MANUFACTURER'S REPORT ADDRESSES LOT TWO (2) OF TWO (2). CONFIRMATION PCR (PLATFORM - UNKNOWN) TESTING WAS PERFORMED ON UNKNOWN DATES AND GENERATED NEGATIVE RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19639221 ↗
• MalfunctionJun 28, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED AN UNKNOWN NUMBER OF FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON UNKNOWN DATES. THE SAMPLE AND SWAB TYPES WERE NOT PROVIDED. THIS MANUFACTURER'S REPORT ADDRESSES LOT ONE (1) OF TWO (2). CONFIRMATION PCR (PLATFORM - UNKNOWN) TESTING WAS PERFORMED ON UNKNOWN DATES AND GENERATED NEGATIVE RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19639126 ↗
• MalfunctionJun 4, 2024False Positive Result; False Positive Result

  THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAX NOW COVID-19 AG CARD KIT AND BINAX NOW COVID-19 AG SELF TEST PERFORMED ON (B)(6) 2024 ON A NASAL SAMPLE. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF TWO (2). CONFIRMATION PCR TESTING (PLATFORM - NAAT) WAS PERFORMED ON (B)(6) 2024 WHICH GENERATED A NEGATIVE RESULT. THE CUSTOMER STATED THAT THE PATIENT IS FINE. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459474 ↗
• MalfunctionMar 21, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED THREE FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD PERFORMED ON (B)(6) 2024. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF THREE (3). CONFIRMATION PCR (PLATFORM - UNKNOWN) TESTING WAS PERFORMED ON (B)(6) 2024 WHICH GENERATED A NEGATIVE RESULT. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC AND WAS NOT ON ANY TREATMENT FOR COVID. PATIENTS WERE TRANSFERRED TO A QUARANTINE AREA DUE TO FALSE POSITIVE RESULT. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18956335 ↗
• MalfunctionMar 21, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED THREE FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD PERFORMED ON (B)(6) 2024. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF THREE (3). CONFIRMATION PCR (PLATFORM - UNKNOWN) TESTING WAS PERFORMED ON (B)(6) 2024 WHICH GENERATED A NEGATIVE RESULT. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC AND WAS NOT ON ANY TREATMENT FOR COVID. PATIENTS WERE TRANSFERRED TO A QUARANTINE AREA DUE TO FALSE POSITIVE RESULT. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18956325 ↗
• MalfunctionMar 21, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED THREE FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD PERFORMED ON (B)(6) 2024. THIS MFR. REPORT ADDRESSES TEST THREE (3) OF THREE (3). CONFIRMATION PCR (PLATFORM - UNKNOWN) TESTING WAS PERFORMED ON (B)(6) 2024 WHICH GENERATED A NEGATIVE RESULT. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC AND WAS NOT ON ANY TREATMENT FOR COVID. PATIENTS WERE TRANSFERRED TO A QUARANTINE AREA DUE TO FALSE POSITIVE RESULT. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18956312 ↗