BinaxNOW COVID-19 Antigen Self Test 195-180Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00811877011729), received between Jan 16, 2024 and Jan 12, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (20 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 27 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionSep 24, 2025False Negative Result; False Positive Result; False Negative Result; False Positive Result

  THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST ON (B)(6) 2025. THE CONSUMER RECEIVED A POSITIVE RESULT ON (B)(6) 2025 AND A NEGATIVE RESULT ON (B)(6) 2025 WITH THE BINAXNOW COVID-19 AG SELF TEST. FURTHER TESTING WAS DONE ON (B)(6) 2025 WITH AN UNKNOWN BRAND, WHICH GAVE A NEGATIVE RESULT. ON (B)(6) 2025, THE CONSUMER PERFORMED ANOTHER TEST WITH THE BINAXNOW COVID-19 AG SELF TEST AND GENERATED A NEGATIVE RESULT. THE CONSUMER WAS SYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23133076 ↗
• MalfunctionJul 16, 2025False Negative Result; False Negative Result

  THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THEIR BINAXNOW COVID-19 AG SELF-TEST TAKEN ON (B)(6) 2025. A DIFFERENT BRAND'S TEST (BRAND UNKNOWN) WAS TAKEN WHICH RETURNED A POSITIVE RESULT ON (B)(6) 2025. THE CONSUMER WAS A FEMALE WITH SYMPTOMS OF SORE THROAT, CONGESTION, AND BODY ACHES. NO ADDITIONAL INFORMATION REGARDING TREATMENT AND OUTCOME WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22523142 ↗
• MalfunctionMay 21, 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 WITH A NASAL SAMPLE. ADDITIONAL TESTING (BRAND UNKNOWN) WAS PERFORMED WITH AN UNKNOWN SAMPLE TYPE AND GENERATED POSITIVE RESULTS. THE CONSUMER REPORTED CALLING 911 THE FOLLOWING DAY DUE TO FEELING WEAK AND DEHYDRATED, AND WERE POSITIVE FOR COVID-19. THE CONSUMER RELAYED THAT THEY ARE PERFECTLY FINE NOW. NO ADDITIONAL INFORMATION ON TREATMENT WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22064100 ↗
• MalfunctionApr 10, 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 NASAL SAMPLE. THE CONSUMER INITIALLY TESTED WITH A INTELISWAB TEST ON (B)(6) 2025 WHICH GENERATED A POSITIVE RESULT. THE CONSUMER STATED THAT SHE WAS ASYMPTOMATIC WHEN TESTED NEGATIVE ON (B)(6) 2025 AND CONFIRMED THAT THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21816561 ↗
• MalfunctionMar 10, 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. PREVIOUS TESTING (IHEALTH COVID-19 ANTIGEN RAPID TEST) WAS PERFORMED ON (B)(6) 2025 GENERATING A POSITIVE RESULT. THE CONSUMER STATED THAT THEY WERE EXPERIENCING SYMPTOMS OF COUGH AND CONGESTION. THE CONSUMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THEIR TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21560570 ↗
• MalfunctionFeb 26, 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 BINAXNOW COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2025. THE CONSUMER ADDED REAGENT SOLUTION TO SWAB AND SWABBED HER NOSE WITH IT. PER THE CONSUMER, SHE DEVIATED FROM THE PROCEDURE, REVERSED IT AND ADDED REAGENT SOLUTION TO SWAB BEFORE USING IT TO SWAB HER NOSE. THE CONSUMER WAS ADVISED TO RINSE HER NOSE WITH WATER AND CONTACT HER HEALTHCARE PROVIDER IF NEEDED. THE CONSUMER CONFIRMED THERE WAS NO IRRITATION, OR ANY DISCOMFORT EXPERIENCED DUE TO THE REAGENT EXPOSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21474674 ↗
• MalfunctionJan 29, 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. A PREVIOUS TEST (ACCESS BIO CARE START) WAS PERFORMED ON (B)(6) 2025 AND GENERATED POSITIVE RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED, INCLUDING DETAILS ABOUT THE TREATMENT AND THE OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264672 ↗
• MalfunctionNov 5, 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. PRIOR PCR CONFIRMATION TESTING WAS PERFORMED ON (B)(6) 2024 AND GENERATED A POSITIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20610539 ↗
• MalfunctionOct 28, 2024False Negative Result; False Negative Result

  THE CONSUMER REPORTED FOUR NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2024. THIS MANUFACTURER'S REPORT ADDRESSES TEST THREE (3) OF FOUR (4), FOR THE WIFE. THE CONSUMER PERFORMED TWO ADDITIONAL BINAXNOW COVID-19 ANTIGEN SELF-TESTS ON UNKNOWN DATES AND GENERATED POSITIVE RESULTS. THE CONSUMER WAS EXPERIENCING SYMPTOMS OF A COUGH, RUNNING NOSE, AND FEELING TIRED. HER DOCTOR MENTIONED THAT SHE NEEDS TO RETAKE THE TEST. THE CONSUMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20553462 ↗
• MalfunctionOct 28, 2024False Negative Result; False Negative Result

  THE CONSUMER REPORTED FOUR NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2024. THIS MANUFACTURER'S REPORT ADDRESSES TEST FOUR (4) OF FOUR (4), FOR THE WIFE. THE CONSUMER PERFORMED TWO ADDITIONAL BINAXNOW COVID-19 ANTIGEN SELF-TESTS ON UNKNOWN DATES AND GENERATED POSITIVE RESULTS. THE CONSUMER WAS EXPERIENCING SYMPTOMS OF A COUGH, RUNNING NOSE, AND FEELING TIRED. HER DOCTOR MENTIONED THAT SHE NEEDS TO RETAKE THE TEST. THE CONSUMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20552774 ↗
• MalfunctionOct 21, 2024False Negative Result; False Negative Result

  THE CONSUMER REPORTED SIX FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON VARIOUS DATES. THIS MANUFACTURER¿S REPORT ADDRESSES PATIENT 1 (TEST QTY 4), TEST TWO (2) OF SIX OF (6). THE CONSUMER PERFORMED A BINAXNOW COVID-19 ANTIGEN SELF-TEST ON (B)(6) 2024 AND GENERATED A NEGATIVE RESULT. ADDITIONAL TESTING WAS PERFORMED WITH THE CVS COVID-19 TEST KIT ON 03OCT2024 AND GENERATED A POSITIVE RESULT. THE CONSUMER WAS EXPERIENCING COUGH, SNEEZING AND FEVER AND CONTACTED THE DOCTOR SINCE HE HAS COPD, WHICH HAD THE SAME SYMPTOMS AS COVID-19. THE CONSUMER WAS ALSO TAKING PAXLOVID. THE CONSUMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494072 ↗
• MalfunctionOct 21, 2024False Negative Result; False Negative Result

  THE CONSUMER REPORTED TWO FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2024. THIS MANUFACTURER'S REPORT ADDRESSES TEST ONE (1) OF TWO (2). CONSUMER PERFORMED TWO ADDITIONAL BINAXNOW COVID-19 ANTIGEN SELF-TESTS ON UNKNOWN DATES AND GENERATED POSITIVE RESULTS. ADDITIONAL TESTING WAS PERFORMED WITH THE CVS COVID-19 TEST KIT ON (B)(6) 2024 AND GENERATED A POSITIVE RESULT. THE CONSUMER WAS EXPERIENCING COUGH, SNEEZING AND FEVER AND CONTACTED THE DOCTOR SINCE HE HAS COPD, WHICH HAD THE SAME SYMPTOMS AS COVID-19. THE CONSUMER WAS ALSO TAKING PAXLOVID. THE CONSUMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494049 ↗
• MalfunctionOct 3, 2024False Negative Result; False Negative Result

  THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED AT AN UNKNOWN DATE. THIS REPORT IS FOR USER ONE (1) OF TWO (2). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED AT AN UNKNOWN DATE. THE CONSUMER VISITED HER HEALTHCARE PROVIDER AND RECEIVED A POSITIVE RESULT WITH A DUAL TEST FOR FLU/COVID (BRAND AND DATE OF TEST UNKNOWN). THE CONSUMER NOTED HAVING SYMPTOMS, BUT SPECIFIC SYMPTOMS WERE NOT PROVIDED. THE CONSUMER MENTIONED BEING IN GOOD HEALTH AND MANAGING HER COVID. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20360723 ↗
• MalfunctionSep 9, 2024False Negative Result; False Negative Result

  THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON (B)(6) 2024. TESTING WAS PERFORMED WITH A COMPETITOR PRODUCT (UNKNOWN AT HOME TEST BRAND) AND GENERATED POSITIVE RESULTS ON THE SAME DAY (B)(6) 2024). NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20169441 ↗
• MalfunctionAug 28, 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. INITIAL TESTING WAS PERFORMED ON (B)(6) 2024 VIA AN UNKNOWN BRAND ANTIGEN TEST WHICH GENERATED A NEGATIVE RESULT. THE CONSUMER INDICATED THEY WERE EXPERIENCING SYMPTOMS SUCH AS A BAD COLD, SNEEZING, AND A RUNNY NOSE. 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 20092831 ↗
• MalfunctionAug 7, 2024False Negative Result; False Negative Result

  THE CONSUMER REPORTED TWO (2) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST FOR TWO TESTS PERFORMED ON (B)(6) 2024. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF TWO (2). ADDITIONAL TESTING WAS PERFORMED ON (B)(6) 2024 WITH FLOWFLEX WHICH GENERATED A POSITIVE RESULT. THE CONSUMER BELIEVED THAT SHE'S INFECTED WITH COVID-19 BECAUSE SHE'S BEEN SICK FOR A WEEK AND ALREADY CONTACTED HER DOCTOR. THE CONSUMER STATED THAT SHE IS NOT FEELING WELL ON (B)(6) 2024. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19927846 ↗
• MalfunctionAug 7, 2024False Negative Result; False Negative Result

  THE CONSUMER REPORTED TWO (2) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST FOR TWO TESTS PERFORMED ON (B)(6) 2024. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF TWO (2). ADDITIONAL TESTING WAS PERFORMED ON (B)(6) 2024 WITH FLOWFLEX WHICH GENERATED A POSITIVE RESULT. THE CONSUMER BELIEVED THAT SHE'S INFECTED WITH COVID-19 BECAUSE SHE'S BEEN SICK FOR A WEEK AND ALREADY CONTACTED HER DOCTOR. THE CONSUMER STATED THAT SHE IS NOT FEELING WELL ON (B)(6) 2024. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19927818 ↗
• MalfunctionAug 5, 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. THE CONSUMER PERFORMED PRIOR TESTING WITH THE BINAXNOW SELF-TEST ON (B)(6) 2024 AND AN UNKNOWN DATE AND BOTH TESTS GENERATED NEGATIVE RESULTS. THE CONSUMER PERFORMED ADDITIONAL TESTING WITH AN IHEALTH COVID TEST ON (B)(6) 2024 AND GENERATED A NEGATIVE RESULT. ON (B)(6) 2024, THE CONSUMER ALREADY HAD SYMPTOMS LIKE FEVER, SORE THROAT, AND HEAD CONGESTION. THE CONSUMER CONTACTED HIS DOCTOR BUT WAS NOT PROVIDED MEDICATION. ON (B)(6) 2024, THE CONSUMER WAS EXPERIENCING SYMPTOMS OF HEAD CONGESTION AND ACHY BODY. THE CONSUMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THEIR TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905517 ↗
• 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 TWO (2) 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 19459498 ↗
• MalfunctionMar 22, 2024False Negative Result; False Negative Result

  THE CONSUMER REPORTED TWO FALSE NEGATIVE RESULTS VIA SOCIAL MEDIA WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON AN UNKNOWN DATE. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF TWO (2). ADDITIONAL TESTING WAS PERFORMED (AT THE CLINIC) ON AN UNKNOWN DATE WITH AN UNKNOWN BRAND TEST (PLATFORM - UNKNOWN) WHICH GENERATED A POSITIVE RESULT. THE CONSUMER STATED THAT THE PATIENT WAS TESTED POSITIVE FOR PNEUMONIA AT THE CLINIC. NO ADDITIONAL INFORMATION, INCLUDING PATIENT TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960594 ↗
• MalfunctionMar 20, 2024False Negative Result; False Negative Result

  THE CONSUMER REPORTED TWO FALSE NEGATIVE RESULTS VIA SOCIAL MEDIA WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON AN UNKNOWN DATE. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF TWO (2). ADDITIONAL TESTING WAS PERFORMED (AT THE CLINIC) ON AN UNKNOWN DATE WITH AN UNKNOWN BRAND TEST (PLATFORM - UNKNOWN) WHICH GENERATED A POSITIVE RESULT. THE CONSUMER STATED THAT THE PATIENT WAS TESTED POSITIVE FOR PNEUMONIA AT THE CLINIC. NO ADDITIONAL INFORMATION, INCLUDING PATIENT TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18947133 ↗
• MalfunctionMar 14, 2024Non Reproducible Results; Non Reproducible Results

  THE CONSUMER REPORTED CONFLICTING RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2024. THE FIRST TEST GENERATED A NEGATIVE RESULT. THE SECOND TEST GENERATED A POSITIVE RESULT. CONFIRMATION TESTING WAS NOT PERFORMED. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18908392 ↗
• MalfunctionFeb 14, 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 ON A NASAL SWAB. ADDITIONAL TESTING WAS PERFORMED ON THE (B)(6) 2024 WITH INBIOS HOME TEST WHICH GENERATED A POSITIVE RESULT. THE CONSUMER STATED THE PATIENT WAS SYMPTOMATIC (HEADACHE, SORE THROAT AND BODY ACHE) NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18704656 ↗