• 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 SCABOROUGH BINAXNOW COVID-19 HOME 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 SCABOROUGH BINAXNOW COVID-19 HOME TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 Back to Search Results
Catalog Number 195-160
Device Problems Contamination (1120); Product Quality Problem (1506)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Investigation: the investigation is still in progress. A supplemental report will be provided after completion.
 
Event Description
The user reports inserting the binaxnow covid-19 antigen self test swab into the nose with solution on the swab. No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBINAXNOW COVID-19 HOME TEST
Type of DeviceLATERAL FLOW IMMUNOASSAY IVD OF COVID-19
Manufacturer (Section D)
ABBOTT DIAGNOSTICS SCABOROUGH
10 southgate road
scarborough ME 04074
Manufacturer Contact
kindra sudduth
10 southgate road
scarborough, ME 04074
6613888803
MDR Report Key12808057
MDR Text Key281766649
Report Number1221359-2021-03497
Device Sequence Number1
Product Code QKP
UDI-Device Identifier00811877011408
UDI-Public01008118770114081722030810156715A
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EUA202537
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number195-160
Device Lot Number156715A
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Date Manufacturer Received05/05/2022
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

-
-