BinaxNOW COVID-19 Ag Card Home Test 195-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00811877011330), received between Mar 27, 2021 and Jun 7, 2023 — classified as 13 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (9 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.

• MalfunctionJun 7, 2023False Negative Result; False Negative Result

  THE CONSUMER REPORTED TWO FALSE NEGATIVE RESULTS WITH BINAX NOW COVID-19 AG ON (B)(6) 2023. THE CONSUMER RECEIVED NEGATIVE RESULTS WITH BINAX NOW COVID-19 AG IN FEBRUARY, AND A POSITIVE RESULT AT THE DOCTOR OFFICE. PER THE CONSUMER, SHE WAS SYMPTOMATIC. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF TWO (2) TESTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083571 ↗
• MalfunctionJun 7, 2023False Negative Result; False Negative Result

  THE CONSUMER REPORTED TWO FALSE NEGATIVE RESULTS WITH BINAX NOW COVID-19 AG ON UNKNOWN DATES. THE CONSUMER RECEIVED NEGATIVE RESULTS WITH BINAX NOW COVID-19 AG IN FEBRUARY, AND A POSITIVE RESULT AT THE DOCTOR OFFICE. PER THE CONSUMER, SHE WAS SYMPTOMATIC. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF TWO (2) TESTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083518 ↗
• InjuryAug 24, 2022Use of Device Problem; Use of Device Problem

  THE CONSUMER REPORTED HAVING A SEVERE ALLERGIC REACTION TO FOAMTECH MEDICAL NASAL SWAB FROM BINAXNOW COVID-19 AG HOME TEST. THE PATIENT REPORTED A VERY PAINFUL REACTION UPON INSERTING THE SWAB INTO THEIR NOSE. THE PATIENT REPORTEDLY EXPERIENCED A TINGLING FEELING THAT DEVELOPED INTO AN INTENSE BURNING SENSATION IN THE THROAT. INTENSE ADDITIONALLY, THE PAIN CAUSED THE PATIENT TO HEAVE. THE PATIENT REPORTEDLY WENT TO THE EMERGENCY ROOM AFTER COMPLETING THE TEST. THE PATIENT HAD NO KNOWN ALLERGIES AND DID NOT CONDUCT ANY ALLERGIC TESTING. THE PATIENT REPORTEDLY USES A NASAL SPRAY DAILY. ALTHOUGH REQUESTED, DETAILS OF THE EMERGENCY ROOM VISIT WERE NOT PROVIDED.

  Patient problems: Burning Sensation; Pain

  MAUDE report 15283713 ↗
• InjuryJul 21, 2022Use of Device Problem; Use of Device Problem

  THE CONSUMER REPORTED POURING REAGENT ON THE SWAB PRIOR TO INSERTING THE SWAB IN HER NOSTRIL. CONSUMER REPORTED A LITTLE BURNING FEELING BUT DISSIPATED AFTER CLEANING WITH WATER. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION INCLUDING TREATMENT AND OUTCOME WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15074464 ↗
• MalfunctionJul 13, 2022False Positive Result; False Positive Result

  THE CONSUMER REPORTED FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON TWO DATES USING TWO LOTS WITH THE KIT SWAB AND A NASAL SAMPLE. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF TWO (2). THE CONSUMER REPORTED TAKING THE TEST ON (B)(6) 2022 AND GETTING A FAINT SAMPLE LINE (POSITIVE), BUT HAD ISOLATED FOR TWO WEEKS WITH NO SYMPTOMS. CONFIRMATION TESTING WAS PERFORMED THE SAME DAY USING AN IHEALTH TEST AND GENERATED A NEGATIVE RESULT. THE CUSTOMER CONFIRMED THERE WAS NO IMPACT OR TREATMENT DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15005804 ↗
• MalfunctionJul 13, 2022False Positive Result; False Positive Result

  THE CONSUMER REPORTED FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD HOME TEST PERFORMED ON TWO DATES USING TWO LOTS WITH THE KIT SWAB AND A NASAL SAMPLE. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF TWO (2). THE CONSUMER REPORTED TAKING THE TEST ON (B)(6) 2022 AND GETTING A FAINT SAMPLE LINE (POSITIVE). CONFIRMATION TESTING WAS PERFORMED THE SAME DAY USING AN IHEALTH TEST AND GENERATED A NEGATIVE RESULT. THE CUSTOMER WAS ASYMPTOMATIC AND CONFIRMED THERE WAS NO IMPACT OR TREATMENT DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15005700 ↗
• MalfunctionJul 13, 2022Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT THE PATIENT WAS TAKING THE BINAXNOW COVID-19 HOME TEST AT A HOTEL AND DURING THE INTERPRETATION OF THE RESULTS, THE PATIENT INDICATED THAT THEY HAD INSERTED THE NASAL SWAB INTO THE TOP HOLE OF THE TEST CARD AND THEN INSERTED THE SWAB INTO THEIR NOSTRIL TO OBTAIN SAMPLE. IT IS CURRENTLY UNKNOWN IF THE PATIENT HAD INITIALLY PLACED THE REAGENT OF THE BINAXNOW COVID-19 HOME TEST IN THE TOP HOLE OF THE TEST CARD AS PER PROCEDURE. NO FURTHER INFORMATION REGARDING PATIENT HEALTH STATUS OR OUTCOME WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14999576 ↗
• InjuryMay 31, 2022Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT THE PATIENT HAD DIPPED THE SWAB INTO THE REAGENT PRIOR TO INSERTING THE SWAB IN THEIR NOSTRIL. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION INCLUDING TREATMENT AND OUTCOME WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14550591 ↗
• InjuryMay 11, 2022Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED INSERTING SWAB INTO NOSTRILS WITH THE REAGENT BEFORE COLLECTING SAMPLE WITH BINAXNOW COVID-19 HOME, TEST WAS PERFORMED ON (B)(6) 2022 . NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14358415 ↗
• InjuryMay 7, 2022Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT THE CONSUMER INSERTED THE SWAB INTO THE TEST CARD (UNKNOWN IF REAGENT HAD BEEN ADDED) AND THEN INSERTED THE SWAB INTO THEIR NOSE. THIS IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION AS THE CUSTOMER WAS NOT ABLE TO PROVIDE ANY ADDITIONAL INFORMATION TO CONFIRM IF THE REAGENT HAD BEEN ADDED PRIOR TO INSERTING THE SWAB INTO THE TEST CARD AND COULD HAVE BEEN EXPOSED TO THE REAGENT. NO FURTHER INFORMATION WILL BE PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14317215 ↗
• MalfunctionMay 4, 2022Non Reproducible Results; Non Reproducible Results

  THE CONSUMER REPORTED A CONFLICTING RESULT WITH THE BINAXNOW COVID-19 HOME TEST ON (B)(6) 2022.THE CONSUMER TOOK A TEST AND GOT A NEGATIVE RESULT, AFTER SOME MINUTES HE STARTED SEEING A SECOND PINK LINE. CONFORMATION TEST WAS NOT PERFORMED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 14281703 ↗
• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED AN INTENSE BURNING SENSATION IN THE NASAL MEBRANE AND A NOSE BLEED VIA MEDWATCH (B)(4). NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Burning Sensation; Epistaxis

  MAUDE report 14274592 ↗
• InjuryApr 28, 2022Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED A PROCEDURAL ERROR WITH BINAXNOW COVID-19 HOME TEST ON (B)(6) 2021. THE CONSUMER PUT THE REAGENT ON THE SWAB , AND INSERTED IN THE NOSTRILS. THE CONSUMER DID NOT PROVIDE IF THEY WERE ASYMPTOMATIC OR SYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 14244689 ↗
• InjuryApr 22, 2022Patient-Device Incompatibility

  THE CONSUMER REPORTED OF DEVELOPING HYPERSENSITIVITY TO NASAL SWAB WITH BINAXNOW COVID-19 HOME TEST ON (B)(6) 2022 .THE PATIENT HAD BEEN TAKING THE TEST 8 TIMES IN PAST 8 WEEKS AT HOME BY HERSELF SHE STARTED BURNING SENSATION THE 2ND OR THIRD TIME OF USING BINAXNOW COVID-19 HOME TEST . ON (B)(6) 2022 HER NOSE STARTED BLEEDING. NO MEDICAL ATTENTION WAS NEEDED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME,WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 14189571 ↗
• MalfunctionFeb 2, 2022Non Reproducible Results; Non Reproducible Results

  THE CONSUMER REPORTED CONFLICTING RESULTS WITH TWO BINAXNOW COVID-19 HOME TESTS PERFORMED. THE FIRST TEST GENERATED A POSITIVE RESULT. THE REPEAT TEST GENERATED A NEGATIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13429289 ↗
• InjuryJan 28, 2022Use of Device Problem; Use of Device Problem

  THE CONSUMER REPORTED THAT WHILE PERFORMING THE BINAXNOW COVID-19 HOME TEST ON (B)(6) 2021, THE REAGENT SOLUTION CAME INTO CONTACT WITH THE EYE. THE CONSUMER FLUSHED THE EYE SEVERAL TIMES. THE CONSUMER CONTACTED TECHNICAL SERVICES (TS) FOR FURTHER GUIDANCE. TS ASKED QUESTIONS TO CLARIFY IF THERE WERE ANY FURTHER ADVERSE EFFECTS TO THE EYE. THE CONSUMER CONFIRMED THAT THEY WERE NOT EXPERIENCING ANY FURTHER ADVERSE EFFECTS TO THE EYE, SUCH AS REDNESS OR BURNING. THE CONSUMER STATED THAT THEY DO NOT PLAN TO SEE A HEALTHCARE PROVIDER FOR THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13388034 ↗
• InjuryJan 18, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CONSUMER REPORTED THAT DURING A TESTING SESSION WITH THE BINAXNOW COVID-19 ANTIGEN CARD HOME TEST, THE PATIENT "GOT INJURED AND STARTED BLEEDING." THE DATE THAT THIS EVENT OCCURRED IS UNKNOWN. NO PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13283277 ↗
• MalfunctionDec 30, 2021Product Quality Problem; Component Missing; Therapeutic or Diagnostic Output Failure

  ABBOTT "BINAXNOW COVID-19 AG CARD HOME TEST", LOT 1413200, DELIVERED WITH EMPTY REAGENT BOTTLE: "COVID-19AG CARD EXTRACTION REAGENT", LOT#: G0126470 / EXP. 10/01/2021. TEST KIT FAILED TO PERFORM DESIRED TEST DUE TO EMPTY REAGENT BOTTLE. EMED WAS PROCTORING THE TEST AND WITNESSED THE FAILURE. MATTER REPORTED TO ABBOTT: CASE (B)(6) MATTER REPORTED TO EMED: TICKET NUMBER: (B)(6), REQUESTED REPLACEMENT KIT, BUT NONE HAS BEEN DELIVERED NOR SCHEDULED. KIT FAILED TO PERFORM TEST. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 13141613 ↗
• MalfunctionDec 29, 2021Expiration Date Error

  ABBOTT BINAXNOW COVID-19 AG CARD HOME TEST RECEIVED TESTS FROM ABBOTT ON 9/21/2021 - THEY WERE SUPPLIED FOC DUE TO A PREVIOUS INVALID TEST. I HAVE (B)(6) TRACKING TO CONFIRM DATE IF NEEDED. TOOK TESTS ON TRIP TO (B)(6). SIGNED ONTO EMED (B)(6) 2021 TO DO TEST. AS PART OF THAT PROCESS YOU REMOVE AN OUTER CARD SLEEVE AND THE PROCTOR SCANS A QR CODE TO VALIDATE THE TEST TYPE/INFORMATION. I WAS INFORMED TEST WAS OUT OF DATE. I HAD TWO ADDITIONAL TESTS - WE CHECKED BOTH - ALL WERE OUT OF DATE. EXPIRY DATE ON TESTS WAS 9/18/2021 MY CONCERNS ARE: TESTS WERE DELIVERED ON 9/21/2021 AND EXP DATE WAS 9/18/2021; DATE DOES NOT HAVE THE WORDING 'EXPIRY OR EXP DATE' NEXT TO IT. IF SAYS 'REF' WHICH COULD MEAN ANYTHING; DATE IS COVERED UP BY CARDBOARD SLEEVE WHICH VERY CLEARLY STATES 'DO NOT REMOVE' MAKING IT IMPOSSIBLE FOR A CONSUMER TO READ THE EXPIRY DATE PRIOR TO ACTUAL USAGE; MAIN PURPOSE OF TEST IS TO TAKE ABROAD WITH YOU TO CARRY OUT PRE-RETURN TO THE USA. IT IS PROACTIVELY MARKETED BY (B)(6), (B)(6) ETC; AS OF 12/28/2021 TESTS HAVE TO BE TAKEN ON THE DAY PRIOR TO FLYING AND THEREFORE IT IS IN A SITUATION LIKE THIS IMPOSSIBLE TO THEN SOURCE/REQUEST AN ALTERNATIVE TEST. WHILE THAT MAY NOT BE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13117891 ↗
• MalfunctionNov 3, 2021False Positive Result; False Positive Result

  THE USER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 HOME TEST PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED NASAL KITTED SWAB. CONFIRMATION TESTING WITH AN UNKNOWN ANTIGEN TEST GENERATED NEGATIVE RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12749967 ↗
• MalfunctionOct 13, 2021Expiration Date Error

  EMED.COM IS ONE OF THE ONLY TWO SITE THAT SELLS THE ABBOT BINAX HOME TEST FOR COVID. I ORDERED IT IN (B)(6) FOR 6-PACK BECAUSE THE EMED SITE POSTED THE FDA LETTER INDICATING SHELF LIFE EXTENDED TO 12 MONTHS. HOWEVER, ONCE I RECEIVED THE TEST, THE EXPIRATION DATE ON THE BOXES IS OCT 15, 2021 (MANUFACTURE DATE 2/8/2021). WHEN I CALLED SUPPORT THEY SAID IT WILL EXPIRES 3 MONTHS AFTER I RECEIVE IT BUT THAT'S NOT WHAT THEY POSTED ONLINE. EVEN I CAN ASSUME SHELF LIFE IS 1 YEAR, WHEN I RECEIVED THE PRODUCT IT'S ALREADY 6 MONTHS PASSED. THE EMED REP I SPOKE TO CHANGED HIS TONE AND SAID IT WILL EXPIRES NEXT FEBRUARY AFTER I PRESSED ON THE FDA LETTER THEY POSTED ONLINE. THIS IS FALSE ADVERTISING AND COULD LEAD TO PEOPLE USING AN EXPIRED TEST. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12632299 ↗
• MalfunctionSep 30, 2021Expiration Date Error

  ORDERED BIAXNOW COVID-19 HOME TEST FROM (B)(6) ON (B)(6) 2021 TO REPLACE KITS PREVIOUSLY ORDERED IN (B)(6) THAT WERE ABOUT TO EXPIRE. RECEIVE THE 6 KITS ON 09/28/2021 AND, AGAIN, KITS ARE SHORT DATED MAKING IT IMPOSSIBLE TO USE SERIALLY OVER TIME. (B)(6) REFUSED TO REPLACE THE KITS. REF: 195-100, LOT: 139380, EXPIRATION: 2021-09-18 (+3 MONTHS EXTENSION). SOLD BY (B)(6). FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12561745 ↗
• MalfunctionSep 27, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST. REPEAT TESTING WAS NOT PERFORMED. CONFIRMATION TESTING AT A TESTING FACILITY GENERATED A NEGATIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12531962 ↗
• InjurySep 23, 2021Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER REPORTED DISCREPANCY RESULTS WITH THE ADD PRODUCT PERFORMED ON (B)(6) 2021 ON AN UNKNOWN SAMPLE. ALTHOUGH REQUESTED NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12519103 ↗
• InjuryJul 31, 2021Use of Device Problem; Use of Device Problem

  THE CONSUMER REPORTED SUSTAINING A NASAL INJURY WHILE USING THE BINAXNOW COVID-19 HOME TEST. THE CONSUMER REPORTED AN UNSPECIFIED AMOUNT BLOOD ON THE SWAB. (B)(6) REPORTED THAT IT WAS UNCLEAR IF THE CONSUMER'S NASAL WAS SWABBED TWICE. (B)(6) ALSO, REPORTED THAT IT APPEARED THE PROCTOR STOPPED THE SESSION BEFORE ANY TESTING COULD TAKE PLACE SO NO ACTUAL TESTING OCCURRED. HOWEVER, AN INVALID RESULT WAS REPORTED. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12257077 ↗