inforMED
MalfunctionPCL

CAPTIA MEASLES IGM ELISA KIT

Received Mar 29, 2021 · Event occurred Feb 10, 2021

Report 1318654-2021-00001 · MDR key 11584644

Device

Generic name

Measles Igm Elisa

Model number

2326060

Catalog number

2326060

Lot number

060

Product problems

  • Unable to Obtain Readings
  • Unable to Obtain Readings

Patient

Not reported

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

Narrative

Description of Event or Problem

LABORATORY USER INFORMED MANUFACTURER THAT CAPTIA MEASLES IGM KIT WAS REPORTING INVALID ASSAYS ON TWO KITS FROM LOT 060 DUE TO POSITIVE CONTROL VALUES BEING ABOVE THE ASSIGNED ISR RANGE. NO INJURY WAS REPORTED.

Remedial action

  • Replace
  • Notification