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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 2 of 6

Device	Model / Reference	Registries	Class	Status
Human Haptoglobin Kit for use on SPAPLUS	NK058.S	FDA UDI	Class II	Unknown
Optilite C1 Inactivator Kit	NK019.OPT.A	FDA UDI	Class II	Active
Optilite Freelite Mx Kappa Free Kit	LK016.M.OPT.A	FDA UDI	Class II	Active
Optilite® Low Level Albumin Control Pack	NQ032.L.OPT	FDA UDI	Class I	Active
Human IgG, IgA, IgM ‘NL’ BINDARID™ COMBI RID Kit	RK002	FDA UDI	Class II	Unknown
Human IgG1 Subclass Liquid Reagent Kit for use on the SPAPLUS –Bulk Kit	NK006.10S	FDA UDI	N/A	Active
Human IgG Control Pack for use on the SPAPLUS®	NQ004.S	FDA UDI	Class I	Active
Human Complement C4 ‘NL’ BINDARID™ Radial Immunodiffusion Kit	RN025.3	FDA UDI	Class II	Active
Human C4 Kit for use on SPAPLUS	NK025.S	FDA UDI	Class II	Unknown
VaccZyme™ Human Anti-Haemophilus Influenzae type b Enzyme Immunoassay Kit	MK016	FDA UDI	Class II	Active
Optilite CH50 Calibrator	NC095.OPT.A	FDA UDI	Class II	Active
Human alpha 1 antitrypsin Kit for use on SPAPLUS	NK034.S	FDA UDI	Class II	Unknown
Human IgG3 Subclass Liquid Reagent Kit for use on Hitachi 911/912/917, Modular P	LK008.H	FDA UDI	Class II	Active
Hevylite® Human IgA Kappa Kit for use on the SPAPLUS	NK623.S.A	FDA UDI	Class II	Active
Tetanus Toxoid IgG Calibrator Set	EA115.A	FDA UDI	Class I	Active
MININEPH™ Human Prealbumin Kit	ZK066.R	FDA UDI	N/A	Unknown
Optilite® IgG3 Kit (x10)	LK008.10.OPT.A	FDA UDI	Class II	Active
Freelite® Human Lambda Free Control Pack for use on the SPAPLUS®	NQ018.S	FDA UDI	Class I	Unknown
Human IgG3 Subclass Liquid Reagent Kit for use on the Siemens BNII Analyser	NK008.T	FDA UDI	Class II	Unknown
Human IgG3 Subclass Liquid Reagent Kit for use on the SPAPLUS- Bulk Kit	LK008.10S	FDA UDI	N/A	Active
Freelite® Human Lambda Free Kit for use on the Hitachi 911/912/917/Modular P	LK018.H	FDA UDI	Class II	Active
Human CH50 controls for use on SPAPLUS	NQ095.S	FDA UDI	Class I	Unknown
Hu IgG4 Subclass Liquid Reagent Kit for use on Hitachi 911/912/917 and Modular P	LK009.H	FDA UDI	N/A	Active
Human IgM - ‘NL’ BINDARID™ Radial Immunodiffusion Kit	RN012.3	FDA UDI	Class II	Unknown
MININEPH™ Human Rheumatoid Factor Kit	ZK151.L.R	FDA UDI	N/A	Unknown
Freelite® Human Lambda Free Control Pack For use on the Roche Cobas Integra®	NQ018.RI	FDA UDI	Class I	Unknown
Human Albumin CSF Kit for use on SPAPLUS	NK032.L.S	FDA UDI	Class II	Active
Human Beta-2 Microglobulin Urine Kit for use on the SPAPLUS	LK043.U.S	FDA UDI	Class II	Active
Freelite® Panel Sample Set	BP228	FDA UDI	Class I	Active
Human Cystatin C Control Pack for use on the SPAPLUS®	NQ048.S	FDA UDI	Class I	Unknown
Optilite Low Level Albumin Kit	NK032.L.OPT.A	FDA UDI	Class II	Active
Human IgG Subclass Liquid Reagent Kit for use on the Siemens BN™II	LK001.TB	FDA UDI	Class II	Unknown
Immunofixation (IFE) Kit	XK001	FDA UDI	Class II	Unknown
Total Haemolytic Complement	RC001.2	FDA UDI	Class II	Active
IgD AMR Fluid	BP506	FDA UDI	Class I	Active
Human C1 Inactivator BINDARID™ Radial Immunodiffusion Kit	RN019.3	FDA UDI	Class II	Active
Optilite® Low Level Total Protein Reagent	NK061.L.OPT.A	FDA UDI	Class I	Active
Hevylite® Human IgM Lambda Kit for use on the SPAPLUS	NK626.S.A	FDA UDI	Class II	Active
Optilite IgM Kit	NK012.OPT.A	FDA UDI	Class II	Active
Human Immunoglobulin D BINDARID™ Radial Immunodiffusion Kit	RN013.3	FDA UDI	Class II	Active
Minifix™ Kit	XK004	FDA UDI	N/A	Unknown
Optilite Hevylite® IgM Lambda Kit	NK626.OPT.A	FDA UDI	Class II	Active
Human IgG4 Subclass Liquid Reagent Kit for use on the Beckman Coulter AU® series	LK009.AU	FDA UDI	Class II	Active
Optilite IgG4 Kit	LK009.OPT.A	FDA UDI	Class II	Active
Human IgG1 Subclass Liquid Reagent Kit for use on the Siemens BN™II	NK006.TB	FDA UDI	Class II	Active
Freelite® Lambda AMR Check Fluid SD	BP539.SD	FDA UDI	Class I	Active
Sheep Anti-Human Kappa Free Light Chains Immunofixation Grade	PX016	FDA UDI	Class II	Unknown
Human IgG Liquid Reagent Kit for use on the SPAPLUS –Bulk Kit	NK004.10S.A	FDA UDI	Class II	Active
Human C3c Control Pack for use on the SPAPLUS®	NQ023.S	FDA UDI	Class I	Unknown
Lipoprotein (a) Kit for use on SPAPLUS	LK098.S	FDA UDI	Class II	Unknown

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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.