inforMED
MalfunctionQKP

BINAXNOW COVID-19 TEST KIT

Received Sep 27, 2023

Report MW5146233 · MDR key 17834344

Device

Generic name

Coronavirus Antigen Detection Test System

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 #MW5146232.