OtherLYR
AVANOS CLOTEST
Received Aug 24, 2023
Report MW5144957 · MDR key 17624345
Device
Generic name
Helicobacter Pylori
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
AVANOS CLOTEST BEING SOLD TO HOSPITALS AS AN FDA APPROVED WAIVED TEST. IT IS NOT LOCATED ON THE FDA ACCESSDATA WEBSITE. HOSPITALS ARE UTILIZING THIS TEST KIT THINKING THEY ARE USING AN FDA APPROVED KIT WHEN IN ACTUALITY THEY ARE NOT AND COULD BE CITED BY CLIA (CMS) FOR UTILIZING AN UNAPPROVED TEST. NOT FDA APPROVED; NOT CLASSIFIED ON THE FDA WEBSITE FOR COMPLEXITY. BEING SOLD TO HOSPITALS SAYING THEY ARE FDA APPROVED AND HAVE BEEN DETERMINED TO BE WAIVED.