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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 3 of 6

Device	Model / Reference	Registries	Class	Status
Human Alpha 1 Antitrypsin NL BINDARID™ Kit	RN034.3	FDA UDI	Class II	Active
Optilite Freelite Kappa Free Bulk Kit	LK016.10.OPT.A	FDA UDI	Class II	Active
MININEPH Human IgG4 Kit	ZK009.L.R	FDA UDI	N/A	Unknown
Freelite® Human Kappa Free Control Pack For use on the Beckman Coulter IMMAGE™/	NQ016.IM	FDA UDI	Class I	Active
Optilite IgG CSF Kit	NK004.L.OPT.A	FDA UDI	Class II	Active
Hevylite® Human IgG Lambda Kit for use on the Siemens BN™II	NK622.T	FDA UDI	N/A	Active
Human IgG4 Subclass Liquid Reagent Kit for use on the Beckman IMMAGE®/IMMAGE®800	LK009.IM	FDA UDI	Class II	Unknown
Optilite IgA2 Kit	LK088.OPT.A	FDA UDI	Class II	Active
Freelite® Human Lambda Free Control Pack for use on the Siemens BN™II	NQ018.T	FDA UDI	Class I	Active
B2M AMR Fluid	BP507	FDA UDI	Class I	Active
Human alpha 1 acid glycoprotein Kit for use on SPAPLUS	NK063.S	FDA UDI	Class I	Unknown
Hevylite IgG Kappa Kit for Siemens BNII	NK621.T.A	FDA UDI	Class II	Active
Human IgG2 Subclass Liquid Reagent Kit for use on the Siemens BN™II - Bulk Kit	NK006.2TB	EUDAMEDFDA UDI	Class II	Active
Tetanus Toxoid IgG Low Control	EA116.L.A	FDA UDI	Class I	Active
General Purpose Reaction Buffer	NB136	FDA UDI	Class I	Active
Freelite® Human Lambda Free Kit for use on the SPAPLUS	LK018.S	FDA UDI	Class II	Active
MININEPH Reagent Accessory Pack	ZK500.R	FDA UDI	N/A	Unknown
Hevylite® Human IgA Kappa Kit for use on the Siemens BN™II	NK623.T.A	FDA UDI	Class II	Active
Human Apolipoprotein A-1 (Apo A-1) kit for use on SPAPLUS	NK085.S	FDA UDI	Class I	Active
Freelite® Human Kappa Free Kit for use on the Siemens ADVIA®	LK016.B	FDA UDI	Class II	Active
Optilite IgM CSF Kit	LK012.L.OPT.A	FDA UDI	Class II	Active
Sheep Anti-Human Lambda Free Light Chains Immunofixation Grade	PX018	FDA UDI	Class II	Unknown
Freelite® Human Lambda Free Kit for use on the Siemens BN™II - Bulk Kit	LK018.10T	FDA UDI	Class II	Active
Freelite® Human Kappa Free Control Pack For use on the Roche Cobas Integra®	NQ016.RI	FDA UDI	Class I	Unknown
Freelite® Human Lambda Free Kit for use on the Beckman Coulter IMMAGE®/IMMAGE®80	LK018.IM	FDA UDI	Class II	Unknown
Complement C2 Calibrator Set	NC022.A	FDA UDI	Class II	Active
CH50 Eq Enzyme Immunoassay Kit	MK095	FDA UDI	Class II	Active
Human IgG1 Subclass Liquid Reagent Kit for use on the Beckman Coulter AU® series	NK006.AU	FDA UDI	Class II	Active
Diptheria Toxoid IgG Calibrator Set	EA068.A	FDA UDI	Class I	Active
Optilite Beta 2 Microglobulin Urine Kit	LK043.L.OPT.A	FDA UDI	Class II	Active
Optilite® α1-Acid Glycoprotein Control Pack	NQ063.OPT	FDA UDI	Class I	Active
Optilite® Beta-2 Microglobulin Kit	LK043.OPT.A	FDA UDI	Class II	Active
Tetanus Toxoid IgG High Control	EA116.A	FDA UDI	Class I	Active
Optilite Anti-Streptolysin-O Kit	LK189.OPT.A	FDA UDI	Class I	Active
Hevylite IgM Lambda Kit for Siemens BNII	NK626.T.A	FDA UDI	Class II	Active
Optilite C4 Kit	NK025.OPT.A	FDA UDI	Class II	Active
Human IgM Control Pack for use on the SPAPLUS®	NQ012.S	FDA UDI	Class I	Unknown
Hevylite Human IgA Lambda SPA Kit	NK624.S.A	FDA UDI	Class II	Active
Human Cystatin C Kit for use on SPAPLUS	LK048.S	FDA UDI	Class II	Unknown
Freelite® Human Kappa Free Control Pack for use on the SPAPLUS®	NQ016.S	FDA UDI	Class I	Unknown
Human IgG2 SPA PLUS Bulk Kit	NK007.10S	FDA UDI	N/A	Active
Human IgG1 Kit for SPAPLUS	NK006.S.A	FDA UDI	Class II	Unknown
MININEPH™ Human Haptoglobin Kit	ZK058.R	FDA UDI	N/A	Unknown
Tetanus Toxoid IgG Conjugate	EA118.A	FDA UDI	Class I	Active
MININEPH Human IgG3 Kit	ZK008.L.R	FDA UDI	N/A	Unknown
Optilite® CH50 Reagent	NK095.OPT.A	FDA UDI	Class II	Active
Human alpha 2 macroglobulin Kit for use on SPAPLUS	NK039.S	FDA UDI	Class II	Unknown
Human CH50 Calibrator set for use on SPAPLUS	NC095.S	FDA UDI	Class II	Unknown
Freelite® Human Kappa Free Kit for use on the Roche cobas® systems – Bulk kit	LK016.10CB	FDA UDI	Class II	Unknown
Optilite® Alpha-1-Antitrypsin Control Pack	NQ034.OPT	FDA UDI	Class I	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.