BinaxNOW COVID-19 Ag Card Home TestRecalls & reported problems across all models
Alere Scarborough, Inc. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls
- 0
We found 2 models of BinaxNOW COVID-19 Ag Card Home Test by Alere Scarborough, Inc. in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between Mar 27, 2021 and Jun 7, 2023 — classified as 16 injuries, 18 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported BinaxNOW COVID-19 Ag Card Home Test problems
Device problems
- Use of Device Problem9
- False Positive Result6
- False Negative Result4
- Non Reproducible Results4
- Adverse Event Without Identified Device or Use Problem3
- Expiration Date Error3
- Insufficient Device Problem Information3
- Component Missing1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Insufficient Information9
- Burning Sensation2
- Epistaxis2
- Hypersensitivity/Allergic reaction1
- Pain1
- Skin Inflammation/ Irritation1
- Unspecified Tissue Injury1
BinaxNOW COVID-19 Ag Card Home Test models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BinaxNOW COVID-19 Ag Card Home Test 195-100Coronavirus Antigen Detection Test System.27 reports
- BinaxNOW COVID-19 Ag Card Home Test 195-200Coronavirus Antigen Detection Test System.7 reports
Recent BinaxNOW COVID-19 Ag Card Home Test adverse event reports
The 15 most recent reports across all models, 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 10, 2022False Negative Result; False Negative Result
THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2021. ON (B)(6) 2021, PCR CONFIRMATION TESTINGS GENERATED POSITIVE RESULT. CONSUMER CONFIRMED SHE WAS SYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13509514 ↗
Other Alere Scarborough, Inc. products
All Alere Scarborough, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page