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

Human Subclass Kit for use on the Beckman recalled

The Binding Site Group is recalling Human Subclass Kit for use on the Beckman Immage"/Immage"800 Analyser Product, distributed nationwide in the US. 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-1067-2017
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: Other Medical Devices

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 Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Product Code LK009.IM 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.

Nationwide California Florida Michigan Minnesota Ohio Tennessee

Questions about this recall

Is Human Subclass Kit for use on the Beckman Immage"/Immage"800 Analyser Product recalled?

Yes. The Binding Site Group recalled Human Subclass Kit for use on the Beckman Immage"/Immage"800 Analyser Product on 11 Sep 2014. The recall is Class II and its status is Terminated. Recall number Z-1067-2017.

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

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