• 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 ANTIGEN SELF TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

  • 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 ANTIGEN SELF TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 Back to Search Results
Catalog Number 195-160
Device Problem Missing Information (4053)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Event Description
The consumer reported that while attempting to open the binaxnow covid-19 antigen self test reagent solution, he experienced a "few drops" in his eyes when the top "snapped off". The ifu does provided instructions for opening the reagent bottle: it says: remove dropper bottle cap. The instructions to remove it are there- just not specifically how. The consumer reported the test kit did not contain instructions for how to open the reagent bottle.
 
Manufacturer Narrative
The investigation is still in progress. A supplemental report will be provided after completion. The reagent sds (safety data sheet) was provided to the consumer.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBINAXNOW COVID-19 ANTIGEN SELF TEST
Type of DeviceLATERAL FLOW IMMUNOASSAY IVD OF COVID-19
Manufacturer (Section D)
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
10 southgate road
scarborough ME 04074
Manufacturer Contact
elissa zavorotny
10 southgate road
scarborough, ME 04074
MDR Report Key12805740
MDR Text Key281832493
Report Number1221359-2021-03394
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
Type of Report Initial,Followup
Report Date 05/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number195-160
Device Lot Number156699A
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Date Manufacturer Received04/21/2022
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 Treatment Data
Date Received: 11/12/2021 Patient Sequence Number: 1
-
-