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

Device recall: Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monit

FDA enforcement event 76050 · Class II · initiated 28 Oct 2016 · status Terminated · terminated 27 Jul 2017

DeviceVoluntary: Firm initiated1 product record

FDA enforcement event 76050 is a device recall by The Binding Site Group, Ltd. of Birmingham, initiated 28 Oct 2016 and classified Class II, with 1 product record.

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. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.

Status: Terminated, terminated 27 Jul 2017. 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, United Kingdom.

Reason for recall

"A change in the calibration curve causing an increase in false prozone flags."

Distribution

"Worldwide Distribution - U.S. (nationwide) and Internationally to the following; Canada, Australia."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1053-2017	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	3,088	Class II	Terminated	25 Jan 2017

Context

91%of 2016 device events are Class II1,232 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
19 Feb 2019	Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitativ	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: "A change in the calibration curve causing an increase in false prozone flags."

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: "Worldwide Distribution - U.S. (nationwide) and Internationally to the following; Canada, Australia."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 27 Jul 2017. "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.