Kappa, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5550
Recent MDR events
55 adverse event reports on file
- Optilite® Freelite® Kappa Free KitJul 29, 2026MalfunctionThe Binding Site Limited9614373-2026-00006
- N LATEX FLC KAPPAJul 7, 2026MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2026-00021
- N LATEX FLC KAPPAJul 7, 2026MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2026-00023
- OPTILITE® FREELITE® KAPPA FREE KIT (X10)Jul 7, 2026InjuryThe Binding Site Limited2083566-2026-00005
- OPTILITE® FREELITE® KAPPA FREE KIT (X10)Jul 6, 2026InjuryThe Binding Site Limited9614373-2026-00005
- OPTILITE® FREELITE® KAPPA FREE KITJun 25, 2026InjuryThe Binding Site Limited2083566-2026-00003
- OPTILITE® FREELITE® KAPPA FREE KITJun 24, 2026MalfunctionThe Binding Site Limited9614373-2026-00003
- OPTILITE® FREELITE® KAPPA FREE KITMar 31, 2026InjuryThe Binding Site Limited2083566-2026-00002
- OPTILITE® FREELITE® KAPPA FREE KITMar 30, 2026InjuryThe Binding Site Limited9614373-2026-00002
- OPTILITE® FREELITE® KAPPA FREE KITMar 11, 2026InjuryThe Binding Site Limited2083566-2026-00001
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- The Binding Site Group, Ltd.TerminatedUnknown
Optilite Freelite Mx Kappa Free Kit
Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstrating a positive bias compared to assigned values.
Z-0943-2021 · View FDA record ↗ - The Binding Site Group, Ltd.TerminatedUnknown
FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK016.CB, IVD CE, UDI:
The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.
Z-2030-2021 · View FDA record ↗
Registered firms
46 firms currently registered for this product code
Sentinel Ch. Spa
MILANO, IT
Agilent Technologies Singapore (international) Pte Ltd.
Singapore North East, SG
Beckman Coulter, Inc.
CARLSBAD, CA, US
Sebia
EVRY Essonne, FR
Siemens Healthcare Diagnostics Products Gmbh
MARBURG Hesse, DE
The Binding Site Group Ltd.
BIRMINGHAM, GB
The Binding Site, Inc.
SAN DIEGO, CA, US
The Binding Site
Kings Norton Birmingham, GB
Interlab S.r.l.
ROME Lazio, IT
Beckman Coulter, Inc.
BREA, CA, US
Agilent Technologies Denmark Aps
GLOSTRUP Hovedstaden, DK
510(k) clearances
63 clearances for this product code
- Diazyme Laboratories, Inc.Dec 19, 2025
K253358 · Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay
- The Binding Site Group , Ltd.May 23, 2025
K250549 · Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit
- SebiaFeb 23, 2024
K231601 · FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2
- The Binding Site, Ltd.Jan 24, 2024
K231290 · Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
- SebiaNov 18, 2022
K210623 · FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2
- Diazyme Laboratories, Inc.Sep 8, 2022
K211648 · Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
- Diazyme Laboratories, Inc.Aug 4, 2022
K220001 · Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
- Siemens Healthcare Diagnostics Products GmbHMar 2, 2022
K212379 · N Latex FLC kappa, N Latex FLC lambda