inforMED
MalfunctionLSL

GENEXPERT SWAB SPECIMEN KIT

Received Aug 16, 2021

Report MW5103294 · MDR key 12331814

Device

Generic name

Dna-reagents, Neisseria

Manufacturer

Cepheid Ab

Product problems

  • Product Quality Problem
  • Use of Device Problem
  • Improper or Incorrect Procedure or Method

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

SWABS USED FOR NASOPHARYNGEAL TESTING ARE ALMOST IDENTICAL IN APPEARANCE AND PACKAGING TO THOSE USED IN STI TESTING EXAMS. THIS RESULTED IN THE INCORRECT SWAB BEING USED FOR AN (B)(6) TEST. THE TEST COULD NOT BE RUN AND AN ALTERNATE SAMPLE HAD TO BE OBTAINED. THE SWABS USED WERE THE CEPHEID GENXPERT AND THE GU CEPHEID GENXPERT. THE ONLY DIFFERENCE IN PACKAGING IS THAT THE NP SWAB STATES "NASOPHARYNGEAL". FDA SAFETY REPORT ID# (B)(4).