Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Problems Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2024
Event Type  malfunction  
Event Description
The consumer reported adding reagent drops from the binaxnow covid-19 antigen self-test to their eyes on an unknown date thinking it as artificial tears.The consumer is doing fine with no issues.Although requested, no additional information including treatment and outcome was provided.
 
Manufacturer Narrative
Date of event provided in section b3 is an approximation, was not provided by consumer.The investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.
 
Event Description
The consumer reported adding reagent drops from the binaxnow covid-19 antigen self-test to their eyes on an unknown date thinking it as artificial tears.The consumer is doing fine with no issues.Although requested, no additional information including treatment and outcome was provided.
 
Manufacturer Narrative
Date of event provided in section b3 is an approximation, was not provided by consumer.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.
 
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 Key19068759
MDR Text Key339787317
Report Number1221359-2024-00330
Device Sequence Number1
Product Code QKP
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 04/23/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 03/27/2024
Initial Date FDA Received04/08/2024
Supplement Dates Manufacturer Received04/17/2024
Supplement Dates FDA Received04/23/2024
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 SexMale
-
-