CLASS II Device recall · Reported 10 Feb 2021 · FDA Enforcement Report

Optilite Freelite Mx Kappa Free Kit recalled by The Binding Site Group

The Binding Site Group is recalling Optilite Freelite Mx Kappa Free Kit, distributed in 10 states. The recall was initiated on 18 Nov 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: LK016.M.OPT.A UDI: 05051700019866 Lot Number: 454763

Quantity recalled213 kits in the U.S.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0943-2021
FDA event ID: 86926
Recalling firm: The Binding Site Group, Birmingham
Classification: Class II
Status: Terminated
Recall initiated: 18 Nov 2020
FDA classified: 1 Feb 2021
Reported: 10 Feb 2021
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

18 Nov 2020	Recall initiated by company
1 Feb 2021	Classified by FDA	+75 days
10 Feb 2021	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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

Where it was distributed

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

Colorado Florida Iowa Massachusetts North Carolina New Jersey New York Ohio South Dakota Utah

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Model Number: LK016.M.OPT.A UDI: 05051700019866 Lot Number: 454763

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from The Binding Site Group

All 29

Reported	Class	Recall	Company	Reason	Where
17 Jun 2026Device	CLASS II	Exent Analyser recalled by The Binding Site Group	The Binding Site Group	Potency & Assay	Nationwide
1 Dec 2021Device	CLASS II	Freelite Human Lambda Free Kit (for use on the Spaplus) recalled	The Binding Site Group	Other	13 states
14 Jul 2021Device	CLASS II	Freelite Human Kappa Free Kit recalled by The Binding Site Group	The Binding Site Group	Other	Nationwide
3 Jun 2020Device	CLASS II	Optilite Rheumatoid Factor Kit recalled by The Binding Site Group	The Binding Site Group	Other	20 states
27 May 2020Device	CLASS II	The Optilite Clinical Chemistry Analyzer recalled	The Binding Site Group	Device Malfunction	Nationwide

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