BinaxNOW COVID-19 Antigen Self Test 195-260Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00811877011415), received between May 28, 2021 and Jan 26, 2024 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2024False Positive Result; False Positive Result

  THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST PERFORMED ON AN UNKNOWN DATE. ADDITIONAL TESTING WAS PERFORMED (AT THE HOSPITAL) ON AN UNKNOWN DATE WITH AN UNKNOWN BRAND (PLATFORM - UNKNOWN) WHICH GENERATED A NEGATIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18591817 ↗
• MalfunctionMay 18, 2022False Negative Result; False Negative Result

  THE CONSUMER REPORTED FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST FOR TWO LOTS PERFORMED ON TWO DATES. THIS MFR. REPORT ADDRESSES LOT ONE (1) OF THREE (3). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2022 ON A NASAL SAMPLE USING THE KIT SWAB. CONFIRMATION TESTING USING ANOTHER BRAND OF RAPID ANTIGEN TEST GENERATED A POSITIVE RESULT. THE CONSUMER STATED THEY WERE ASYMPTOMATIC ON (B)(6) 2022 AND SYMPTOMS WERE ABATING ON (B)(6) 2022. THE PATIENT REPORTEDLY RECEIVED MONOCLONAL ANTIBODY TREATMENT AND OVER-THE-COUNTER COLD MEDICINE ON (B)(6) 2022. THIS WAS REPORTED TO FDA IN MEDWATCH REPORT MW5109146.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14432261 ↗
• MalfunctionMar 22, 2022False Positive Result; False Positive Result

  HE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST. SHE PERFORMED AN UNKNOWN TEST WITH HER DOCTOR AND STILL GOT A POSITIVE RESULT. THE PATIENT WAS ASYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED." .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13845512 ↗
• InjuryFeb 16, 2022Use of Device Problem; Use of Device Problem

  THE CONSUMER REPORTED THAT WHILE ADDING THE REAGENT TO THE UPPER HOLE IN THE BINAXNOWCOVID-19 ANTIGEN SELF TEST THE DROPPER SQUIRTED A LITTLE AMOUNT AND A DROP OF REAGENT GOT ONTO THE CONSUMER'S LIPS. CONSUMER DID NOT REPORT ANY IRRITATION OR PAIN AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13544350 ↗
• MalfunctionFeb 7, 2022False Negative Result; False Negative Result

  THE USER REPORTED A FALSE NEGATIVE RESULT WITH THE ID BINAXNOW COVID-19 ANTIGEN SELF TEST. THE USER REPORTED THAT THEIR INITIAL BINAXNOW COVID-19 ANTIGEN SELF TEST RESULT WAS NEGATIVE. REPEAT TESTING WITH BINAXNOW COVID-19 SELF TEST GENERATED POSITIVE RESULTS. CONFIRMATION TESTING WITH PCR GENERATED POSITIVE RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13477159 ↗
• MalfunctionFeb 4, 2022Non Reproducible Results; Non Reproducible Results

  THE CONSUMER REPORTED CONFLICTING RESULTS WITH TWO BINAXNOW¿ COVID-19 ANTIGEN SELF TESTS PERFORMED ON (B)(6) 2022. THE RESULT FROM THE FIRST TEST WAS NEGATIVE. THE REPEAT TEST GENERATED A POSITIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13456882 ↗
• MalfunctionJan 23, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED CONFLICTING RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST ON A DIRECT TESTED NASAL KITTED SWAB. THE CUSTOMER FIRST TESTED WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST AND RECEIVED POSITIVE RESULTS. REPEAT TESTING WAS PERFORMED WITH AN UNSPECIFIED RAPID TEST AND GENERATED NEGATIVE RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13330298 ↗
• MalfunctionJan 22, 2022False Positive Result; False Positive Result

  THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2021. CONFIRMATION TESTING WAS PERFORMED TWICE ON THE SAME DAY WITH AN AT-HOME PCR MACHINE/NUCLEIC ACID TEST OFFERED BY CUE HEALTH AND GENERATED NEGATIVE RESULTS. THE CONSUMER STATED THAT HE WAS SYMPTOMATIC FOR ONE DAY. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13324675 ↗
• MalfunctionJan 19, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  THE CONSUMER REPORTED THAT THE BINAXNOW COVID-19 ANTIGEN SELF-TEST SWAB PACKAGING CONTAINED A "HAIR INSIDE THE WRAPPER." THE DATE OF THIS REPORTED EVENT IS UNKNOWN. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13291737 ↗
• InjuryDec 28, 2021Use of Device Problem; Use of Device Problem

  THE USER REOPORTED SHE GOT (2) TWO DROPS OF THE REAGENT SOLUTION ON HER HAND AND HAS A SMALL RED SPOT THAT'S A BIT IRRITATED. THE USER REPORTED SHE HAS ALREADY WASHED AND RINSED HER HAND MULTIPLY TIMES BUT SHE DID NOT DO IT IMMEDIATELY. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 13092827 ↗
• MalfunctionSep 9, 2021False Negative Result; False Negative Result

  THE CONSUMER REPORTED A UNCONFIRMED FALSE NEGATIVE RESULT WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2021. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12450194 ↗
• MalfunctionSep 7, 2021False Negative Result; Non Reproducible Results; False Negative Result; Non Reproducible Results

  THE CONSUMER REPORTED A CONFLICTING RESULT WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST PERFORMED ON 16AUG2021. CONSUMER STATED HE WAS NOT FEELING OKAY. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12436942 ↗
• MalfunctionAug 24, 2021False Positive Result; False Positive Result

  THE CONSUMER REPORTED A UNCONFIRMED FALSE POSITIVE RESULT WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2021 ON A NASAL KITTED SWAB. REPEAT TESTING WAS NOT PERFORMED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12363195 ↗
• MalfunctionMay 28, 2021False Negative Result; False Negative Result

  THE CONSUMER REPORTED AN UNCONFIRMED FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST. THE CUSTOMER ALSO REPORTED A VERTICAL RED LINE BY THE SWAB AREA. THE CONSUMER CONFIRMED THAT THE PATIENT IS SYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING PATIENT OUT COME WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11900250 ↗