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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 2CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 2CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. Back to Search Results
Catalog Number 195-160
Device Problems Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/30/2023
Event Type  malfunction  
Event Description
The consumer reported reagent exposure to their nose while using binaxnow covid-19 ag self test on (b)(6) 2023 with a nasal sample.The consumer reported they inserted the swab into the card and mixed it with the reagent drops before collecting the sample from their nostrils.No additional information, including patient outcome or treatment, was provided.
 
Manufacturer Narrative
The remainder of the investigation remains in progress.A supplemental report will be provided after completion.H3 other text : other - device not returned; single use device.
 
Event Description
The consumer reported reagent exposure to their nose while using binaxnow covid-19 ag self test on (b)(6) 2023 with a nasal sample.The consumer reported they inserted the swab into the card and mixed it with the reagent drops before collecting the sample from their nostrils.No additional information, including patient outcome or treatment, was provided.
 
Manufacturer Narrative
A product deficiency was not reported or found.The reported health status is anticipated in nature and severity for binaxnow covid-19 ag card risk documentation.A supplemental report will be provided if any additional is obtained.H3 other text : other - device not returned; single use device.
 
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Brand Name
BINAXNOW COVID-19 AG SELF TEST 2CT
Type of Device
CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
Manufacturer (Section D)
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
10 southgate road
scarborough ME 04074
Manufacturer Contact
rachel blackwell
10 southgate road
scarborough, ME 04074
6613888803
MDR Report Key18520311
MDR Text Key333230449
Report Number1221359-2024-00069
Device Sequence Number1
Product Code QKP
UDI-Device Identifier00811877011408
UDI-Public00811877011408
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EUA210264
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/25/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue Number195-160
Was Device Available for Evaluation? No
Date Manufacturer Received01/17/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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