inforMED
MalfunctionJRY

EBV IGM KIT

Received Aug 7, 1996 · Event occurred Jun 1, 1996

Report MW1009661 · MDR key 35044

Device

Generic name

Diagnostic Reagent For Epstein-barr

Catalog number

EB150-E

Lot number

6CLBXR

Product problems

  • False Positive Result
  • Incorrect Or Inadequate Test Results

Patient

NA

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

SEROLOGIC TESTING USING EPSTEIN-BARR VIRUS IGM KIT HAS YIELDED APPARENT FALSE POSITIVE RESULTS.