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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 4 of 6

Device	Model / Reference	Registries	Class	Status
Human IgG Subclass Liquid Reagent Kit for use on the Siemens BN™II Bulk Kit	NK001.T	FDA UDI	Class II	Unknown
Optilite Alpha-1-antitrypsin Kit	NK034.OPT.A	FDA UDI	Class II	Active
Diptheria Toxoid IgG High Control	EA069.A	FDA UDI	Class I	Active
Sheep Anti-Human IgD Immunofixation Grade	PX013	FDA UDI	Class II	Unknown
Optilite CH50 Controls	NQ095.OPT.A	FDA UDI	Class I	Active
Human IgA - ‘NL’ BINDARID™ Radial Immunodiffusion Kit	RN010.3	FDA UDI	Class II	Unknown
Human IgA Liquid Reagent Kit for use on SPAPLUS	NK010.S	FDA UDI	Class II	Unknown
Human IgA2 Subclass Liquid Latex Reagent Kit for use on the Siemens BN™II	LK088.1T	FDA UDI	Class II	Active
Optilite Freelite Kappa Kit	LK016.OPT.A	FDA UDI	Class II	Active
MININEPH™ Human IgM Kit	ZK012.R	FDA UDI	N/A	Unknown
Human Complement C5 BINDARID™ Radial Immunodiffusion Kit	RN027.3	FDA UDI	Class II	Active
Human IgG Subclass Liquid Reagent Kit for use on the Siemens BN™II - Bulk Kit	LK001.2TB	FDA UDI	Class II	Unknown
Human IgG Liquid Reagent Kit for use on the SPAPLUS	NK004.S.A	FDA UDI	Class II	Unknown
Human IgA CSF Kit for use on SPAPLUS	LK010.L.S	FDA UDI	Class II	Unknown
Optilite Haptoglobin Kit	NK058.OPT.A	FDA UDI	Class II	Active
Freelite® Human Lambda Free Kit for use on the ADVIA®	LK018.B	FDA UDI	Class II	Active
Human Antithrombin III BINDARID™ Radial Immunodiffusion Kit	RN040.3	FDA UDI	Class II	Active
Rheumatoid Factor (RF) Kit for use on SPAPLUS	LK151.S.A	FDA UDI	Class II	Active
Optilite IgA Kit	NK010.OPT.A	FDA UDI	Class II	Active
Human Plasminogen ’NL’ BINDARID™ Radial Immunodiffusion Kit	RN065.3	FDA UDI	Class I	Active
Human IgM kit for use on SPAPLUS- Bulk Kit	NK012.10S	FDA UDI	Class II	Active
Anti-Human Complement C2 Latex Reagent	LK022.A	FDA UDI	Class I	Unknown
Human Beta-2 Microglobulin NANORID Radial Immunodiffusion Kit	GT043.3	FDA UDI	Class II	Unknown
Optilite Hevylite® IgA Lambda Kit	NK624.OPT.A	FDA UDI	Class II	Active
Optilite Freelite Mx Lambda Free Kit	LK018.M.OPT.A	FDA UDI	Class II	Active
Hevylite® Human IgM Kappa Kit for use on the SPAPLUS	NK625.S.A	FDA UDI	Class II	Active
Human Apolipoprotein B (Apo B) kit for use on SPAPLUS	NK086.S	FDA UDI	Class I	Active
Human IgD Kit for use on SPAPLUS	LK013.S	FDA UDI	Class II	Active
Human IgG3 Subclass Single Dilution BINDARID™ Kits	RN108.3	FDA UDI	Class II	Active
Human Beta-2 Microglobulin Kit for use on the SPAPLUS	LK043.S	FDA UDI	Class II	Unknown
Human IgG2 Subclass Hitachi Kit	NK007.H	FDA UDI	Class II	Active
Human IgG1 Subclass Liquid Reagent Kit for use on Hitachi 911/912/917 and Hitach	NK006.H	FDA UDI	Class II	Active
Optilite Hevylite® IgA Kappa Kit	NK623.OPT.A	FDA UDI	Class II	Active
Freelite® Human Lambda Free Kit for use on the Roche Cobas Integra®	LK018.RI	FDA UDI	Class II	Unknown
Optilite CH50 Reagent	NK095.OPT.A	FDA UDI	Class II	Unknown
Freelite® Human Lambda Free Kit for use on the Roche cobas® c systems – Bulk Kit	LK018.10CB	FDA UDI	Class II	Unknown
Freelite® Human Kappa Free Kit for use on the SPAPLUS – Bulk Kit	LK016.10S	FDA UDI	Class II	Unknown
Human C1 Inactivator Kit for use on SPAPLUS	NK019.S.A	FDA UDI	Class II	Unknown
Human IgG2 Kit for SPAPLUS	NK007.S.A	FDA UDI	Class II	Unknown
Anti-Human IgA - Particle - ASR pack	MA010	FDA UDI	Class I	Active
MININEPH Human IgG2 Kit	ZK007.R	FDA UDI	N/A	Unknown
Human IgG Liquid Reagent Kit for use on the SPAPLUS –Bulk Kit	NK004.10S	FDA UDI	N/A	Active
Optilite IgG1 Kit	NK006.OPT.A	FDA UDI	Class II	Active
Freelite® Human Kappa Free Control Pack for use on the Siemens BN™II	NQ016.T	FDA UDI	Class I	Active
MININEPH™ Human Albumin Kit	ZK032.R	FDA UDI	N/A	Unknown
Olympus IgG3 Kit	LK008.AU	FDA UDI	Class II	Active
Optilite Albumin Kit	NK032.OPT.A	FDA UDI	Class II	Active
Optilite® Caeruloplasmin Control Pack	NQ045.OPT	FDA UDI	Class I	Active
Optilite C-Reactive Protein Controls	NQ044.OPT.A	FDA UDI	Class II	Active
Hevylite IgA Lambda Kit for Siemens BNII	NK624.T.A	FDA UDI	Class II	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.