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The Binding Site Group

Last updated May 24, 2026

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Country: US
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Catalogue (283)

Page 1 of 6

Device	Model / Reference	Registries	Class	Status
Human IgG1 Subclass Single Dilution BINDARID™ Kits	RN106.3	FDA UDI	Class II	Active
Hevylite IgM Kappa Kit for Siemens BNII	NK625.T.A	FDA UDI	Class II	Active
Optilite Alpha-1-Acid Glycoprotein Kit	NK063.OPT.A	FDA UDI	Class I	Active
Human IgG Subclass Single Dilution BINDARID™ Kit - Bulk Kit	RK021	FDA UDI	Class II	Active
Human Caeruloplasmin Kit for use on SPAPLUS	NK045.S	FDA UDI	Class II	Unknown
Freelite® Human Kappa Free Kit for use on the Beckman AU® series	LK016.AU	FDA UDI	Class II	Active
Diptheria Toxoid IgG Low Control	EA070.A	FDA UDI	Class I	Active
Freelite Kappa Free Panel Sample Set	BP233	FDA UDI	Class I	Active
Human IgG2 Subclass Liquid Reagent Kit for use on the Siemens BN™II - Bulk Kit	NK007.2TB	FDA UDI	Class II	Active
Optilite Alpha-2-macroglobulin Kit	NK039.OPT.A	FDA UDI	Class II	Active
Antistreptolysin O AMR Fluid	BP529	FDA UDI	Class I	Active
Human IgG2 SPA PLUS Bulk Kit	NK007.10S.A	FDA UDI	Class II	Active
MININEPH™ Human IgA Kit	ZK010.R	FDA UDI	N/A	Unknown
Human Haptoglobin BINDARID™ Radial Immunodiffusion Kit	RN058.3	FDA UDI	Class II	Active
Human IgA1 Kit SPAplus	NK087.S	FDA UDI	Class II	Unknown
A1 Acid Glycoprotein AMR Fluid	BP527	FDA UDI	Class I	Active
Human IgG2 Subclass Single Dilution BINDARID™ Kits	RN107.3	FDA UDI	Class II	Active
MININEPH™ Human C4 Kit	ZK025.R	FDA UDI	N/A	Unknown
Human IgG2 Subclass Liquid Reagent Kit for use on the Siemens BNII	NK007.TB	FDA UDI	Class II	Active
Human IgG - ‘NL’ BINDARID™ Radial Immunodiffusion Kit	RN004.3	FDA UDI	Class II	Unknown
Human Beta-2 Microglobulin Control Pack for use on the SPAPLUS®	NQ043.S	FDA UDI	Class I	Unknown
Hevylite Human IgG Kappa Kit for use on the SPAPLUS	NK621.S.A	FDA UDI	Class II	Active
Human IgA kit for use on SPAPLUS- Bulk Kit	NK010.10S	FDA UDI	Class II	Active
Optilite Freelite Lambda Kit	LK018.OPT.A	FDA UDI	Class II	Active
Optilite Cystatin C Kit	LK048.OPT.A	FDA UDI	Class II	Active
Freelite Lambda Free Panel Sample Set	BP234	FDA UDI	Class I	Active
Optilite Rheumatoid Factor Kit	LK151.OPT.A	FDA UDI	Class II	Active
Human IgG3 Subclass Single Dilution BINDARID™ Kits	RN109.3	FDA UDI	Class II	Active
C-Reactive Protein Kit for SPAPLUS	NK044.S.A	FDA UDI	Class II	Unknown
Hevylite Human IgG Lambda Kit for use on the SPAPLUS	NK622.S.A	FDA UDI	Class II	Active
Optilite High Sensitivity C-Reactive Protein Kit	LK044.L.OPT.A	FDA UDI	Class II	Active
Optilite C-Reactive Protein Reagent	NK044.OPT.A	FDA UDI	Class II	Active
Tetanus Toxoid Coated EIA Plates	EA114.A	FDA UDI	Class I	Active
Human C4 Control Pack for use on the SPAPLUS®	NQ025.S	FDA UDI	Class I	Unknown
Human IgG4 SPA PLUS Bulk Kit	LK009.10S.A	FDA UDI	Class II	Active
Human Prealbumin Kit for use on SPAPLUS	NK066.S	FDA UDI	Class I	Unknown
Sheep Anti-Human IgE Immunofixation Grade	PX014	FDA UDI	Class II	Active
Anti-Human IgG - Particle - ASR pack	MA004	FDA UDI	Class I	Active
Optilite® C1 Inactivator Control Pack	NQ019.OPT	FDA UDI	Class I	Active
Human Transferrin Kit for use on SPAPLUS	NK070.S	FDA UDI	N/A	Unknown
Freelite® Human Kappa Free Kit for use on the SPAPLUS	LK016.S	FDA UDI	Class II	Unknown
Optilite® Rheumatoid Factor Control Pack	NQ151.OPT	FDA UDI	Class I	Active
Optilite IgD Kit	LK013.OPT.A	FDA UDI	Class II	Active
Human Microalbumin Kit for use on SPAPLUS	NK032.U.S.A	FDA UDI	Class II	Active
Human Beta-2 Microglobulin Latex Kit for use on the Siemens BN™II	LK043.T	FDA UDI	Class II	Unknown
Freelite® Human Kappa Free Kit for use on the Beckman Coulter IMMAGE®/IMMAGE®800	LK016.IM	FDA UDI	Class II	Active
Human Albumin NL BINDARID™ Radial Immunodiffusion Kit	RN032.3	FDA UDI	Class II	Active
MININEPH™ Human IgG Kit	ZK004.R	FDA UDI	N/A	Unknown
Total Haemolytic Complement	RC001.3	FDA UDI	Class II	Active
Human C-Reactive Protein ‘EL’ NANORID Radial Immunodiffusion Kit	GT044.3	FDA UDI	N/A	Active

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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.