MalfunctionDBF
INTEGRA FERRITIN
Received Aug 30, 2002 · Event occurred Aug 22, 2002
Report 1823260-2002-00273 · MDR key 414575
Device
Product problems
- Malfunction
Patient
NA
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
SOME SERA MAY UNDER-RECOVER FERRITIN BY UP TO 35% IN THE RANGE OF 100 MG/ML TO 500 NG/ML. UNDER-RECOVERY IS CAUSED BY A SAMPLE SPECIFIC MATRIX EFFECT.
Remedial action
- Recall