Is this your brand? Sign in to claim ownership.

The Binding Site Group

Last updated May 24, 2026

Information

Country: US
Address: —
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: —

Catalogue (283)

Page 5 of 6

Device	Model / Reference	Registries	Class	Status
Freelite® Human Lambda Free Kit for use on the Beckman AU® series	LK018.AU	FDA UDI	Class II	Active
MININEPH Sample Diluent Pack	ZK502.R	FDA UDI	N/A	Unknown
Human Transferrin BINDARID™ Radial Immunodiffusion Kit	RN070.3	FDA UDI	Class II	Unknown
Hu IgG Subclass Liquid Reagent Kits for use on Hitachi 911/912/917 and Modular P	LK001.H	FDA UDI	Class II	Active
Optilite IgA CSF Kit	LK010.L.OPT.A	FDA UDI	Class II	Active
MININEPH™ Human C3 Kit	ZK023.R	FDA UDI	N/A	Unknown
MININEPH Human IgG1 Kit	ZK006.R	FDA UDI	N/A	Unknown
Optilite® Transferrin Control Pack	NQ070.OPT	FDA UDI	Class I	Active
Optilite Hevylite® IgM Kappa Kit	NK625.OPT.A	FDA UDI	Class II	Active
Human IgA1 Subclass BNII Kit	NK087.1T	FDA UDI	Class II	Active
Human IgG1 Subclass Liquid Reagent Kit for use on the Beckman IMMAGE®/IMMAGE®800	NK006.IM	FDA UDI	Class II	Unknown
Human Caeruloplasmin NL BINDARID™ Radial Immunodiffusion Kit	RN045.3	FDA UDI	Class II	Active
Freelite® Human Lambda Free Kit for use on the Roche Cobas Integra® - Bulk kit	LK018.10RI	FDA UDI	Class II	Active
Human Albumin Kit for use on SPAPLUS	NK032.S	FDA UDI	N/A	Unknown
Human IgG Subclass Control Pack for use on the SPAPLUS®	NQ006.S	FDA UDI	Class I	Unknown
Optilite® IgG Kit (x10)	NK004.10.OPT.A	FDA UDI	Class II	Active
Freelite® Human Kappa Free Kit for use on the Siemens BN™II - Bulk Kit	LK016.10T	EUDAMEDFDA UDI	Class II	Active
Freelite® Human Kappa Free Kit for use on the HITACHI 911/912/917/Modular P	LK016.H	FDA UDI	Class II	Active
Human IgA2 Kit for use on SPAPLUS	LK088.S	FDA UDI	Class II	Unknown
MININEPHPLUS On Board Buffer (4 Bottles)	SN107.4	FDA UDI	N/A	Active
Optilite Hevylite IgG Kappa Kit	NK621.OPT.A	FDA UDI	Class II	Active
Human IgG4 Kit for SPAPLUS (U.S Only)	LK009.S.A	FDA UDI	Class II	Unknown
Optilite® Haptoglobin Control Pack	NQ058.OPT	FDA UDI	Class I	Active
Optilite IgG3	LK008.OPT.A	FDA UDI	Class II	Active
Freelite® Human Kappa Free Kit for use on the Roche Cobas Integra®	LK016.RI	FDA UDI	Class II	Unknown
Human IgM kit for use on SPAPLUS	NK012.S	FDA UDI	Class II	Unknown
Freelite® Human Kappa Free Kit for use on the Roche Cobas Integra® - Bulk kit	LK016.10RI	FDA UDI	Class II	Active
Optilite Caeruloplasmin Kit	NK045.OPT.A	FDA UDI	Class II	Active
Anti-Human Total Kappa - Particle - ASR pack	MA015	FDA UDI	Class I	Active
Human Complement C3 ‘NL’ BINDARID™ Radial Immunodiffusion Kit	RN023.3	FDA UDI	Class II	Active
Beckman Immage IgG3 Latex Kit	LK008.IM	FDA UDI	Class II	Unknown
Anti-Human IgM - Particle - ASR pack	MA012	FDA UDI	Class I	Active
Optilite C-Reactive Protein Calibrator	NC044.OPT.A	FDA UDI	Class II	Active
Freelite® Human Lambda Free Kit for use on the SPAPLUS – Bulk Kit	LK018.10S	FDA UDI	Class II	Active
Optilite Freelite Lambda Free Bulk Kit	LK018.10.OPT.A	FDA UDI	Class II	Active
Optilite C3c Kit	NK023.OPT.A	FDA UDI	Class II	Active
Human IgG4 Subclass BNII Kit	NK009.T	FDA UDI	Class II	Unknown
Freelite® Human Lambda Free Control Pack For use on the Beckman Coulter IMMAGE™	NQ018.IM	FDA UDI	N/A	Active
MININEPH™ Human Anti-Streptolysin O Kit	ZK189.L.R	FDA UDI	N/A	Unknown
Hevylite® Human IgG Kappa Kit for use on the Siemens BN™II	NK621.T	FDA UDI	N/A	Active
Human Anti Streptolysin-O kit for use on SPAPLUS	LK189.S	FDA UDI	Class I	Unknown
Human IgA Control Pack for use on the SPAPLUS®	NQ010.S	FDA UDI	Class I	Unknown
Optilite IgA1 Kit	NK087.OPT.A	FDA UDI	Class II	Active
Optilite Hevylite IgG Lambda Kit	NK622.OPT.A	FDA UDI	Class II	Active
Optilite IgG Kit	NK004.OPT.A	FDA UDI	Class II	Active
Optilite Transferrin Kit	NK070.OPT.A	FDA UDI	Class II	Active
Total Haemolytic Complement	RC001.1	FDA UDI	Class II	Active
Optilite IgG2 Kit	NK007.OPT.A	FDA UDI	Class II	Active
Human CH50 Reagent pack for use on the SPAPLUS	NK095.S	FDA UDI	Class II	Unknown
Freelite® Kappa AMR Check Fluid SD	BP538.SD	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (28)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Oct 15, 2021	Z-0274-2022	—	terminated	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.
May 20, 2021	Z-2030-2021	—	terminated	The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.
Nov 18, 2020	Z-0943-2021	—	terminated	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.
Apr 9, 2020	Z-2071-2020	—	terminated	A software issue that may affect the analyzer's result accuracy.
Nov 6, 2019	Z-1500-2020	—	terminated	It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference material RF serum. This could result in reporting falsely abnormal results which may lead to unnecessary additional serological testing.
Oct 7, 2019	Z-2110-2020	—	terminated	Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to aid in the diagnosis of rheumatoid arthritis over recovers by 7% in comparison to the reference material RF serum. This could result in reporting abnormal (false positive) results, which may lead to unnecessary additional serological testing and a delay in treatment.
Jul 29, 2019	Z-1327-2020	—	terminated	There is a potential that users may experience difficulty validating the calibration of the kit. This is indicated by kit control values reporting outside the specified ranges. This could result in potential false patient results which could cause a delay until repeat testing is performed.
Apr 25, 2019	Z-1619-2020	—	terminated	A reagent in C reactive protein kits is not performing to specification and samples with known concentrations less-than-or-equal to 10 mg/L may be affected
Feb 19, 2019	Z-0671-2020	—	terminated	Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits
Nov 6, 2018	Z-0604-2019	—	terminated	Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This is indicated by kit control values reporting outside the specified ranges.
Aug 12, 2018	Z-1469-2020	—	terminated	A deterioration of performance was identified with influenza type B Enzyme Immunoassay Kits with findings of a positive bias with kit controls. Patient sample results may be affected with falsely elevated results incorrectly indicating a protective level of anti-Hib antibody in the assessment of immunodeficiency.
Jul 25, 2018	Z-0477-2019	—	terminated	After running the calibration curve, the recovery of the IgM kit control results decrease demonstrating a reduction in accuracy within the same day; control results may be out of range one day after running the assay calibration curve. Samples have been shown to be similarly affected.
Mar 9, 2018	Z-1301-2018	—	terminated	The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.
Jan 4, 2018	Z-0553-2018	—	terminated	The low and high controls for the product are returning results above the assigned values.
Aug 23, 2017	Z-0002-2018	—	terminated	The high control for the kit is recovering low and may be out of range for assigned values.
Dec 23, 2016	Z-1089-2017	—	terminated	A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the information provided in the product insert
Oct 28, 2016	Z-1053-2017	—	terminated	A change in the calibration curve causing an increase in false prozone flags.
Jul 5, 2016	Z-1043-2017	—	terminated	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.
May 13, 2015	Z-1018-2017	—	terminated	Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position.
Sep 11, 2014	Z-1068-2017	—	terminated	Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
Sep 11, 2014	Z-1071-2017	—	terminated	Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
Sep 11, 2014	Z-1073-2017	—	terminated	Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
Sep 11, 2014	Z-1072-2017	—	terminated	Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
Sep 11, 2014	Z-1067-2017	—	terminated	Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
Sep 11, 2014	Z-1070-2017	—	terminated	Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
Sep 11, 2014	Z-1069-2017	—	terminated	Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
Nov 28, 2012	Z-1050-2017	—	terminated	Calibration curve activity has increased over time in the kit lots listed.
Oct 9, 2012	Z-1055-2017	—	terminated	If a control ring is marked after reading, the software will not flag results that are out of the specified QC range.