CLASS II Device recall · Reported 1 Feb 2017 · FDA Enforcement Report

Human lgG Subclass Liquid Reagent Kits recalled

The Binding Site Group is recalling Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ Analyser, distributed in California, Florida, Michigan, Minnesota, Ohio, Tennessee. The recall was initiated on 11 Sep 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots.

Quantity recalledN/A

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-1072-2017
FDA event ID: 76041
Recalling firm: The Binding Site Group, Birmingham, N/A
Classification: Class II
Status: Terminated
Recall initiated: 11 Sep 2014
FDA classified: 23 Jan 2017
Reported: 1 Feb 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

11 Sep 2014	Recall initiated by company
23 Jan 2017	Classified by FDA	+865 days
1 Feb 2017	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

Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.

Product as listed by the FDA

Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ Analyser Product Code: NK001.T This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents

Where it was distributed

Worldwide Distribution - US including n FL, OH, TN, MN, NW, MI, CA. and Internationally to Canada, France, UK, Spain, Germany, Czech Republic, Belgium, Italy, Australia, Brazil, Chile, China, Costa Rica, Kuwait, New Zealand, Oman, Pakistan, Portugal, Sweded, Taiwan, and Turkey.

California Florida Michigan Minnesota Ohio Tennessee

Questions about this recall

Why was it recalled?

Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.

Which lots are affected?

All lots.

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.

Other products in this recall event

6 other products · FDA event 76041

This product is part of a recall event; the main page for the event is Human lgG4 Subclass kit for use on the Beckman Coulter AU" recalled.

Reported	Class	Recall	Company	Reason	Where
1 Feb 2017	CLASS II	Human lgG4 Subclass kit for use on the Beckman Coulter AU" recalled	The Binding Site Group	Other	6 states
1 Feb 2017	CLASS II	Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 recalled	The Binding Site Group	Other	6 states
1 Feb 2017	CLASS II	MininephThl Human lgG4 Kit Product recalled by The Binding Site Group	The Binding Site Group	Other	6 states
1 Feb 2017	CLASS II	Human Subclass Kit for use on the Beckman recalled	The Binding Site Group	Other	6 states
1 Feb 2017	CLASS II	Human lgG4 Subclass Liquid Reagent Kits For use recalled	The Binding Site Group	Other	6 states
1 Feb 2017	CLASS II	Human lgG4 Subclass Liquid Reagent Kits recalled	The Binding Site Group	Other	6 states

More recalls from The Binding Site Group

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14 Jul 2021Device	CLASS II	Freelite Human Kappa Free Kit recalled by The Binding Site Group	The Binding Site Group	Other	Nationwide
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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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