Device recall: Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A

Class II FDA enforcement event 86926. Recall start date: 18 Nov 2020. Status in the FDA record: Terminated. Termination date: 23 Dec 2024.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

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

The Binding Site Group, Ltd. started this device recall on 18 Nov 2020. The firm address in the FDA record is in Birmingham. FDA put the recall in Class II. FDA event 86926 has 1 product record. The first FDA enforcement report date is 10 Feb 2021. The record gives the status Terminated, with the termination date 23 Dec 2024.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

U.S.: CO, FL, IA, MA, NC, NJ, NY, OH, SD, and UT. O.U.S.: Not provided

Recalling firm

The Binding Site Group, Ltd., Birmingham, United Kingdom.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 86926: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0943-2021	Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A	213 kits in the U.S.	Class II	Terminated	10 Feb 2021

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2020: 916
Share of these events in Class II: 93%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 23

Other events of the firm

Other FDA enforcement events of 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
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
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

The Binding Site Group, Ltd.: all 23 events

Official channels

FDA enforcement report Z-0943-2021The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 86926. https://recallregister.com/fda/ii/86926/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: U.S.: CO, FL, IA, MA, NC, NJ, NY, OH, SD, and UT. O.U.S.: Not provided
What quantity of product is in FDA event 86926?: The FDA record gives this quantity: 213 kits in the U.S.
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2020 have the same class?: 93% of the 916 device events that started in 2020 are in Class II.