MalfunctionQKP
BINAXNOW COVID-19 TEST KIT
Received Sep 27, 2023
Report MW5146232 · MDR key 17834335
Device
Generic name
Coronavirus Antigen Detection Test System
Manufacturer
Abbott Diagnostics Korea Inc.Patient
71 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A REPORTER CALLED TO COMPLAIN ABOUT HOW A BINAXNOW TEST KIT IS NOT USER FRIENDLY. SHE SAID THE DROPPER IS HARD TO PRESS. SHE WENT ON TO SAY THAT THERE ARE OTHER TYPES OF DROPPERS THAT WORK MUCH MORE EASILY. SHE ALSO SAID, ACCORDING TO THE INSTRUCTION, ONE IS SUPPOSED TO SQUIRT 6 DROPS AND SHE WAS WORRIED THAT THERE IS A POSSIBILITY ONE MISTAKENLY PUTS LESS OR MORE AND IT COULD HAVE A FALSE NEGATIVE RESULT. REFERENCE REPORT #MW5146233.