CLASS II Device recall · Reported 25 Jan 2017 · FDA Enforcement Report

Human Lambda Free SPAPlus Kit Product recalled by The Binding Site Group

The Binding Site Group is recalling Human Lambda Free SPAPlus Kit, distributed in 11 states. The recall was initiated on 28 Nov 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #323278, 327963

Quantity recalled1,002

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-1050-2017
FDA event ID: 76049
Recalling firm: The Binding Site Group, Birmingham
Classification: Class II
Status: Terminated
Recall initiated: 28 Nov 2012
FDA classified: 19 Jan 2017
Reported: 25 Jan 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

28 Nov 2012	Recall initiated by company
19 Jan 2017	Classified by FDA	+1513 days
25 Jan 2017	Published in enforcement report	+6 days

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

Reason for recall

Calibration curve activity has increased over time in the kit lots listed.

Product as listed by the FDA

Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.

Where it was distributed

U.S. distribution to the following; CA, TX, HI, GA, PA, UT, NY, OK, ID, MA, AZ. Foreign distribution to the following; Australia, Bulgaria, Denmark, Hong Kong, Ireland, Israel, Japan, New Zealand, Taiwan, Belgium, France, Italy, Spain.

Arizona California Georgia Hawaii Idaho Massachusetts New York Oklahoma Pennsylvania Texas Utah

Questions about this recall

Why was it recalled?

Calibration curve activity has increased over time in the kit lots listed.

Which lots are affected?

Lot #323278, 327963

Where was it sold?

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
10 Feb 2021Device	CLASS II	Optilite Freelite Mx Kappa Free Kit recalled by The Binding Site Group	The Binding Site Group	Other	10 states
3 Jun 2020Device	CLASS II	Optilite Rheumatoid Factor Kit recalled by The Binding Site Group	The Binding Site Group	Other	20 states

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