• Decrease font size
  • Return font size to normal
  • Increase font size
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.

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Problem No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/24/2024
Event Type  malfunction  
Manufacturer Narrative
Fda udi - (b)(4).The remainder of the investigation remains in progress.A supplemental report will be provided after completion.H3 other text : single use; device discarded.
 
Event Description
The consumer reported accidental reagent exposure to her eye with a binaxnow covid-19 antigen self-test on (b)(6) 2024.Per the consumer, the reagent solution splashed on her one eye.No additional information was provided.
 
Manufacturer Narrative
Fda udi - (b)(6) a product deficiency was not reported or found.Technical service provided the safety data sheet and advised the consumer to contact their health provider if any irritation occurred.A supplemental report will be provided if any additional information is obtained.The reported health status is anticipated in nature and severity for binaxnow covid-19 ag card risk documentation.H3 other text : single use; device discarded.
 
Event Description
The consumer reported accidental reagent exposure to her eye with a binaxnow covid-19 antigen self-test on (b)(6)2024.Per the consumer, the reagent solution splashed on her one eye.The consumer washed her eye immediately and confirmed she was not having any irritation or burning sensation.Consumer did not require any further medical intervention and there was no reported patient impact.The consumer confirmed there was no death or serious injury.No additional information was provided.
 
Manufacturer Narrative
Fda udi - (b)(4).The remainder of the investigation remains in progress.A supplemental report will be provided after completion.H6 - health effect - impact code h3 other text : single use; device discarded.
 
Event Description
The consumer reported accidental reagent exposure to her eye with a binaxnow covid-19 antigen self-test on (b)(6) 2024.Per the consumer, the reagent solution splashed on her one eye.The consumer washed her eye immediately and confirmed she was not having any irritation or burning sensation.Consumer did not require any further medical intervention and there was no reported patient impact.The consumer confirmed there was no death or serious injury.No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key18702017
MDR Text Key335411316
Report Number1221359-2024-00173
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,Followup
Report Date 03/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date01/14/2024
Device Catalogue Number195-160
Device Lot Number205734
Was Device Available for Evaluation? No
Date Manufacturer Received03/04/2024
Was Device Evaluated by Manufacturer? No
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;
Patient SexFemale
-
-