MalfunctionDFH
Optilite® Freelite® Kappa Free Kit
Received Jul 29, 2026 · Event occurred May 5, 2026
Report 9614373-2026-00006 · MDR key 50068558
Device
Generic name
Optilite® Freelite® Kappa Free Kit
Manufacturer
The Binding Site LimitedModel number
LK016.OPTCatalog number
LK016.OPT
Lot number
544501
Product problems
- High Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions