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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 6 of 6

Device	Model / Reference	Registries	Class	Status
Human Complement C1q BINDARID™ Radial Immunodiffusion Kit	RN020.3	FDA UDI	Class II	Active
Human IgG2 Subclass Kit for use on the Beckman Coulter AU® series	NK007.AU	FDA UDI	Class II	Active
Human IgG1 SPA PLUS Bulk Kit	NK006.10S.A	FDA UDI	Class II	Active
Human IgG2 Subclass Liquid Reagent Kit for use on the Beckman IMMAGE®/IMMAGE®800	NK007.IM	FDA UDI	Class II	Unknown
Human IgG2 Subclass BNII Kit	NK007.T	FDA UDI	Class II	Unknown
Optilite® Prealbumin Control Pack	NQ066.OPT	FDA UDI	Class I	Active
Optilite Prealbumin Kit	NK066.OPT.A	FDA UDI	Class I	Active
Human Fibrinogen BINDARID™ Radial Immunodiffusion Kit	RN056.3	FDA UDI	Class II	Unknown
Hevylite IgG Lambda Kit for Siemens BNII	NK622.T.A	FDA UDI	Class II	Active
Human IgD Control Pack for use on the SPAPLUS®	NQ013.S	FDA UDI	Class I	Active
Human IgG4 Subclass Liquid Reagent Kit for use on the SPAPLUS- Bulk Kit	LK009.10S	FDA UDI	N/A	Active
Optilite® IgG4 Kit (x10)	LK009.10.OPT.A	FDA UDI	Class II	Active
Optilite® Low Level IgG Control Pack	NQ004.LL.OPT	FDA UDI	Class I	Active
Human IgG3 Kit for SPAPLUS	LK008.S.A	FDA UDI	Class II	Unknown
Human IgM CSF Kit for use on SPAPLUS	LK012.L.S	FDA UDI	Class II	Unknown
Human IgD Control Pack for use on the Siemens BN™II	NQ013.T	FDA UDI	Class I	Active
Optilite® IgG2 Kit (x10)	NK007.10.OPT.A	FDA UDI	Class II	Active
Human C3c Kit for use on the SPAplus	NK023.S	FDA UDI	Class II	Unknown
MININEPH™ Human Microalbumin Kit	ZK032.U.R	FDA UDI	N/A	Unknown
Serum Protein Electrophoresis (SPE) Kit	XK003	FDA UDI	Class II	Unknown
Anti-Human Total Lambda - Particle - ASR pack	MA017	FDA UDI	Class I	Active
IgG SC AMR Set	BP504	FDA UDI	Class I	Active
Human IgG CSF Kit for use on SPAPLUS	NK004.L.S	FDA UDI	Class II	Active
Human Protein C ‘NL’ NANORIDTM Radial Immunodiffusion Kit	GT118.3	FDA UDI	Class II	Unknown
Complement C2 Control Pack	NQ022.A	FDA UDI	Class I	Active
Human IgA Subclass NL BINDARID™ Radial Immunodiffusion Kit – Bulk Kit	RK015	FDA UDI	Class II	Unknown
Human Prealbumin BINDARID™ Radial Immunodiffusion Kit	RN066.3	FDA UDI	Class I	Active
MININEPH™ Human C-Reactive Protein Kit	ZK044.L.R	FDA UDI	N/A	Unknown
Optilite® IgG1 Kit (x10)	NK006.10.OPT.A	FDA UDI	Class II	Active
Human IgG1 Subclass Liquid Reagent Kit for use on the Siemens BN™II Analyser	NK006.T	FDA UDI	Class II	Active
Human IgG3 SPA PLUS Bulk Kit	LK008.10S.A	FDA UDI	Class II	Active
Cystatin C AMR Fluid	BP514	FDA UDI	Class I	Active
C-Reactive Protein Kit for use on SPAPLUS	K161982	FDA 510(k)	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.