Lambda, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5550
Recent MDR events
82 adverse event reports on file
- N LATEX FLC LAMBDAJul 7, 2026MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2026-00024
- N LATEX FLC LAMBDAJul 7, 2026MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2026-00022
- OPTILITE® FREELITE® LAMBDA FREE KITJul 2, 2026InjuryThe Binding Site Limited2083566-2026-00004
- OPTILITE® FREELITE® LAMBDA FREE KITJul 1, 2026MalfunctionThe Binding Site Limited9614373-2026-00004
- N LATEX FLC LAMBDAApr 9, 2026MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2026-00008
- N LATEX FLC LAMBDAJan 15, 2026MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2026-00002
- OPTILITE® FREELITE® LAMBDA FREE KITOct 7, 2025MalfunctionThe Binding Site Limited9614373-2025-00002
- OPTILITE® FREELITE® LAMBDA FREE KITOct 7, 2025InjuryThe Binding Site Limited2083566-2025-00002
- N LATEX FLC LAMBDASep 29, 2025MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2025-00049
- N LATEX FLC LAMBDAJun 13, 2025MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2025-00021
Event type breakdown
Recalls
4 recall events for this product code
- The Binding Site Group, Ltd.TerminatedJan 19, 2017
Human Lambda Free SPAPlus Kit
Calibration curve activity has increased over time in the kit lots listed.
Z-1050-2017 · View FDA record ↗ - The Binding Site Group, Ltd.TerminatedJan 19, 2017
Freelite Human Lambda Free Kit for use on SPAPLUS
A change in the calibration curve causing an increase in false prozone flags.
Z-1053-2017 · View FDA record ↗ - The Binding Site Group, Ltd.TerminatedJan 18, 2017
Optilite Freelite Lambda Free Kit
Batch numbers listed are reporting Lambda Free Light Chain results >114mg/L that are on average 33% lower than other Optilite Lambda Freelite batches. Therefore users moving to this batch will see results >114mg/L giving lower results and conversely when switching to the next batch results will be seen to shift upwards.
Z-1043-2017 · View FDA record ↗ - The Binding Site Group, Ltd.TerminatedUnknown
Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S
Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and calibrator point 6, which can be exacerbated with calibrator 6 activity reaches the optical ceiling of the SPA+ analyzer.
Z-0274-2022 · View FDA record ↗
Registered firms
57 firms currently registered for this product code
Beckman Coulter, Inc.
CARLSBAD, CA, US
Sebia
EVRY Essonne, FR
Siemens Healthcare Diagnostics Products Gmbh
MARBURG Hesse, DE
Agilent Technologies Inc.
Cedar Creek, TX, US
The Binding Site Group Ltd.
BIRMINGHAM, GB
The Binding Site, Inc.
SAN DIEGO, CA, US
Sentinel Ch. Spa
MILANO, IT
The Binding Site
Kings Norton Birmingham, GB
Interlab S.r.l.
ROME Lazio, IT
Agilent Technologies Denmark Aps
GLOSTRUP Hovedstaden, DK
Agilent Technologies Singapore (international) Pte Ltd.
Singapore North East, SG
Beckman Coulter, Inc.
BREA, CA, US
510(k) clearances
53 clearances for this product code
- Ventana Medical Systems, Inc.May 8, 2018
K172471 · VENTANA CD30 (Ber-H2) RxDx Assay
- The Binding Site Group , Ltd.Apr 16, 2014
K140396 · FREELITE HUMAN LAMBDA FREE KIT
- SENTINEL CH. SpAJun 22, 2009
K083601 · LAMBDA LIGHT CHAINS
- The Binding Site, Ltd.Jan 30, 2004
K033811 · FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER
- The Binding Site, Ltd.Jul 15, 2003
K031016 · FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II
- The Binding Site, Ltd.Jan 21, 2003
K023131 · FREELITE HUMAN LAMBDA FREE KIT
- The Binding Site, Ltd.Apr 26, 2001
K010440 · FREELITE LAMBDA FREE KIT
- The Binding Site, Ltd.Apr 26, 2001
K010441 · FREELITE KAPPA FREE KIT