Food, drugs, devices › The Binding Site Group, Ltd.

Device recall: Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitativ

FDA enforcement event 84243 · Class II · initiated 19 Feb 2019 · status Terminated · terminated 27 Apr 2021

DeviceVoluntary: Firm initiated1 product recordBirmingham, N/A

The Binding Site Group, Ltd. (Birmingham, N/A) initiated this device recall on 19 Feb 2019; FDA lists 1 product record under event 84243, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.

Status: Terminated, terminated 27 Apr 2021. Initiation: voluntary: firm initiated. The Binding Site Group, Ltd. has 23 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

The Binding Site Group, Ltd., Birmingham, N/A, United Kingdom.

Reason for recall

"Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits"

Distribution

"US Nationwide distribution in the states of CA and GA. OUS not provided due to product being manufacture OUS"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0671-2020	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 Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to…	10 kits	Class II	Terminated	18 Dec 2019

Context

88%of 2019 device events are Class II968 events that year

1product record in this eventfirm median: 1

23events on this register for the firm

Other enforcement events for The Binding Site Group, Ltd.

Initiated	Product (first record)	Type	Class	Records
16 Apr 2026	Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product D	Device	Class II	1
15 Oct 2021	Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPL	Device	Class II	1
20 May 2021	FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas	Device	Class II	1
18 Nov 2020	Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A	Device	Class II	1
9 Apr 2020	The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Cli	Device	Class II	1
6 Nov 2019	Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 050517000183	Device	Class II	1
7 Oct 2019	Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four co	Device	Class II	1
29 Jul 2019	OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565	Device	Class II	1
25 Apr 2019	C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,	Device	Class II	1
6 Nov 2018	Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum,	Device	Class II	1

All 23 events for The Binding Site Group, Ltd.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US Nationwide distribution in the states of CA and GA. OUS not provided due to product being manufacture OUS"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 27 Apr 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.