Data / Medical devices / United Kingdom / The Binding Site Group Ltd.

The Binding Site Group Ltd.: FDA-registered device maker in Birmingham, United Kingdom, 64 510(k) clearances

Name: The Binding Site Group Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

The Binding Site Group Ltd. is registered with the FDA (registration 9614373) in Birmingham, United Kingdom. It lists 49 device types. The FDA files 64 510(k) clearances under its listings, the newest dated October 17, 2025. 23 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch The Binding Site Group Ltd.

FDA registration number: 9614373
FEI number: 3002808340
Address: 8 Calthorpe Road Edgbaston, Birmingham, United Kingdom, B15 1QT
Owner or operator: THE BINDING SITE (9008308)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler
First device listed: August 28, 1996
Registered through: 2026
Brand names listed: ANIT-HAEMOPHILUS B ELI, Alpha 1 Acid Glycoprotein AMR Fluid, Antistreptolysin O AMR Fluid, B2M Analytical Measuring Range Fluid, C1q complement NL RID kit, CH50 ELISA assay, Complement C2 Calibrator Set, Cystatin C Analytical Measuring Range and more

Devices it lists

Device	Product code	Class	Role	Source
Albumin, Antigen, Antiserum, Control	DCF	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control	LKL	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Alpha-1-Antitrypsin, Antigen, Antiserum, Control	DEM	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Alpha-2-Macroglobulin, Antigen, Antiserum, Control	DEB	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Antisera, All Types, H. Influenza	GRP	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Antiserum, Fluorescent, C. Diphtheriae	GOS	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Antistreptolysin - Titer/Streptolysin O Reagent	GTQ	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Antithrombin Iii Quantitation	JBQ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
C-Reactive Protein, Antigen, Antiserum, And Control	DCK	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Calibrator, Multi-Analyte Mixture	JIX	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Calibrator, Primary	JIS	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Ceruloplasmin, Antigen, Antiserum, Control	DDB	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control	DBA	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Complement C1q, Antigen, Antiserum, Control	DAK	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Complement C3, Antigen, Antiserum, Control	CZW	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Complement C4, Antigen, Antiserum, Control	DBI	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Complement C5, Antigen, Antiserum, Control	DAY	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Complement C9, Antigen, Antiserum, Control	DAE	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Cuvette, Thermostated	JRI	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Electrophoretic, Protein Fractionation	CEF	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Haptoglobin, Antigen, Antiserum, Control	DAD	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Igal Heavy & Light Chain Combined	OPY	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Igd, Antigen, Antiserum, Control	CZJ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Ige, Antigen, Antiserum, Control	DGC	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Immunoglobulin A Kappa Heavy & Light Chain Combined	OPX	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Immunoglobulin G Kappa Heavy And Light Chain Combined	PCN	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Immunoglobulin G Lambda Heavy And Light Chain Combined	PCO	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Immunoglobulin M Kappa Heavy And Light Chain Combined	PDE	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Immunoglobulin M Lambda Heavy And Light Chain Combined	PDF	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Kappa, Antigen, Antiserum, Control	DFH	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Lambda, Antigen, Antiserum, Control	DEH	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Mass Spectrometer For Clinical Multiplex Test Systems	OTA	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Mass Spectrometric, Immunoglobulins (G, A, M, D, E)	SGG	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Method, Nephelometric, Immunoglobulins (G, A, M)	CFN	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Plasminogen, Antigen, Antiserum, Control	DDX	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Plates And Equipment, Radial Immunodiffusion	JZQ	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Prealbumin, Antigen, Antiserum, Control	JZJ	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Reagents, Specific, Analyte	MVU	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Test, Beta-2-Microglobulin Immunological	JZG	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Test, C-Reactive Protein	DCN	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Test, Rheumatoid Factor	DHR	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Test, Cystatin C	NDY	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Total Spinal-Fluid, Antigen, Antiserum, Control	DFI	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Transferrin, Antigen, Antiserum, Control	DDG	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 17, 2025	K250159	Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser	SGG	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
May 23, 2025	K250549	Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit	DFH	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
January 24, 2024	K231290	Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit	DFH	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
August 19, 2019	K191985	Optilite IgA Kit	CFN	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
July 15, 2019	K191635	Optilite IgM Kit	CFN	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
May 28, 2019	K190686	Optilite IgM CSF Kit	CFN	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
January 23, 2019	K183151	Optilite IgA CSF Kit	CFN	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
October 12, 2018	K180099	Optilite High Sensitivity C-Reactive Protein Kit	DCN	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
August 23, 2018	K173732	Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit	DFH	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
February 28, 2018	K172868	Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls	DCN	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
February 15, 2018	K172613	Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit	PCN	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
May 3, 2017	K162263	Optilite Rheumatoid Factor Kit	DHR	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
October 4, 2016	K161854	Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS	PCN	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
August 25, 2016	K153560	Optilite Low Level Albumin Kit	DCF	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
June 16, 2016	K160819	Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit	OPX	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
December 18, 2015	K152389	Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit	PDE	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
November 6, 2015	K151759	Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS	OPX	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
August 28, 2015	K150412	Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator	DAE	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
August 26, 2015	K150658	Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit	DFH	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
May 30, 2015	K150526	Optilite IgG4 Kit	CFN	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
May 26, 2015	K143118	Human Microalbumin kit for use on SPAPLUS	DCF	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
December 21, 2014	K142735	The Optilite IgG3 kit	CFN	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
August 6, 2014	K140686	HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS	PDE	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
July 18, 2014	K141100	OPTILITE C1 INACTIVATOR KIT	DBA	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
April 16, 2014	K140664	HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS	DEB	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
March 18, 2014	K140105	HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII	OPX	Substantially Equivalent	The Binding Site	accessdata.fda.gov
December 20, 2013	K132555	HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT	PCN	Substantially Equivalent	The Binding Site	accessdata.fda.gov
July 3, 2013	K123256	HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS	DEM	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
June 19, 2013	K121045	HUMAN ALBUMIN CSF KIT	DCF	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
June 3, 2013	K122965	HUMAN CAERULOPLASMIN KIT	DDB	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
May 17, 2013	K120749	HUMAN IGG CSF KIT	CFN	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
March 27, 2013	K113823	HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT	CFN	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
February 13, 2013	K120236	TRANSFERRIN KIT FOR USE ON THE SPAPLUS	DDG	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
August 30, 2012	K122066	HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS	JZG	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
September 3, 2010	K100455	SPAPLUS ANALYZER	DBI	Substantially Equivalent	The Binding Site	accessdata.fda.gov
August 16, 2010	K100588	HUMAN IGA2 KIT FOR USE ON THE SPAPLUS	CFN	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
August 13, 2010	K100179	SPAPLUS	CZW	Substantially Equivalent	The Binding Site Group , Ltd.	accessdata.fda.gov
December 30, 2009	K090920	HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)	CFN	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
December 28, 2009	K092450	HUMAN IGD KIT FOR USE ON SPAPLUS	CZJ	Substantially Equivalent	The Binding Site	accessdata.fda.gov
May 6, 2009	K083289	HUMAN BETA-2 MICROGLOBULIN KIT	JZG	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
February 10, 2009	K082129	HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER	CFN	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
December 19, 2008	K081827	HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS	CFN	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
February 1, 2008	K072889	HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER	CFN	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
January 24, 2008	K072166	CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER	NDY	Substantially Equivalent	The Binding Site	accessdata.fda.gov
November 30, 2007	K070900	FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT	DFH	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
November 23, 2005	K051299	IGD DIAGNOSTIC TEST KITS	CZJ	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
September 6, 2005	K051915	FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER	DFH	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
November 22, 2004	K042152	BINDING SITE IGG SUBLCASS OLYMPUS KITS	CFN	Substantially Equivalent	The Binding Site	accessdata.fda.gov
March 11, 2004	K040009	FREELITE HUMAN KAPPA AND LAMBDA KITS	DFH	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
January 30, 2004	K033811	FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER	DEH	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
July 15, 2003	K031016	FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II	DEH	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
August 31, 2001	K012292	HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB	CFN	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
April 26, 2001	K010441	FREELITE KAPPA FREE KIT	DEH	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
April 26, 2001	K010440	FREELITE LAMBDA FREE KIT	DEH	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
October 26, 2000	K002560	SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT	DGC	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
December 20, 1999	K981785	C4 MININEPH ANTISERUM	DBI	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
December 4, 1998	K981912	HUMAN IGA SUBCLASS BNII COMBI KIT	CFN	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
July 29, 1998	K974111	QUIDEL CH50 EQ EIA	DAE	Substantially Equivalent	Quidel Corp.	accessdata.fda.gov
August 24, 1995	K942326	HUMAN C5 RID KITS	DAY	Substantially Equivalent	Jay H. Geller	accessdata.fda.gov
January 3, 1992	K913667	ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT	JBQ	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
December 20, 1991	K913672	PREALBUMIN IMMUNOLOGICAL NL TEST KIT	JZJ	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
December 20, 1991	K913668	CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT	DDB	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
October 28, 1991	K914388	C1 RID KIT	DAK	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
July 22, 1991	K905633	HUMAN C-REACTIVE PROTEIN RID KIT	DCK	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 16, 2026	98830	Class II	Ongoing	Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXENT Analyser is an automated analyser intended for the qualitative and quantitativ	It was reported that plates 2 and 3 were marked as passed, although it appeared that QC had not been performed on these plates, despite samples being measured. The potential clinical hazards include false or missed detection of M-protein (false positive); and falsely elevated or decreased M-protein concentration.	accessdata.fda.gov
October 15, 2021	88921	Class II	Terminated	Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S	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.	accessdata.fda.gov
May 20, 2021	88064	Class II	Terminated	FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK016.CB, IVD CE, UDI: 05051700012096	The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.	accessdata.fda.gov
November 18, 2020	86926	Class II	Terminated	Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A	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.	accessdata.fda.gov
April 9, 2020	85492	Class II	Terminated	The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of an	A software issue that may affect the analyzer's result accuracy.	accessdata.fda.gov
November 6, 2019	84909	Class II	Terminated	Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A., UDI: 05051700018319	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.	accessdata.fda.gov
October 7, 2019	85366	Class II	Terminated	Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)	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 treat	accessdata.fda.gov
July 29, 2019	84729	Class II	Terminated	OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565	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.	accessdata.fda.gov
April 25, 2019	84890	Class II	Terminated	C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456	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	accessdata.fda.gov
February 19, 2019	84243	Class II	Terminated	Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site O	Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits	accessdata.fda.gov
November 6, 2018	81421	Class II	Terminated	Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum.	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.	accessdata.fda.gov
August 12, 2018	84899	Class II	Terminated	VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage: This assay is designed for the in vitro measurement of specific IgG antibodies aga	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.	accessdata.fda.gov
July 25, 2018	81409	Class II	Terminated	Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum.	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.	accessdata.fda.gov
March 9, 2018	79499	Class II	Terminated	Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K. The Optilite Beta-2-Microglobulin (2M) Urine kit is intended for t	The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.	accessdata.fda.gov
January 4, 2018	78934	Class II	Terminated	Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor	The low and high controls for the product are returning results above the assigned values.	accessdata.fda.gov
August 23, 2017	78047	Class II	Terminated	Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The Binding Site Group Ltd., Birmingham, UK. Product is designed for the quantitative in-vitro determination	The high control for the kit is recovering low and may be out of range for assigned values.	accessdata.fda.gov
December 23, 2016	76131	Class III	Terminated	Optilite IgG4 Kit Product Code: LK009.OPT.A	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	accessdata.fda.gov
October 28, 2016	76050	Class II	Terminated	Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma and related diseases	A change in the calibration curve causing an increase in false prozone flags.	accessdata.fda.gov
July 5, 2016	76048	Class II	Terminated	Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.	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.	accessdata.fda.gov
May 13, 2015	75898	Class II	Terminated	Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to th	Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position.	accessdata.fda.gov
September 11, 2014	76041	Class II	Terminated	Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Product Code LK009.IM This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series.	Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.	accessdata.fda.gov
November 28, 2012	76049	Class II	Terminated	Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.	Calibration curve activity has increased over time in the kit lots listed.	accessdata.fda.gov
October 9, 2012	76043	Class II	Terminated	Digital RID Plate Reader and Software Product Code: AD400	If a control ring is marked after reading, the software will not flag results that are out of the specified QC range.	accessdata.fda.gov

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Updated June 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.