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

Digital RID Plate Reader recalled by The Binding Site Group

The Binding Site Group is recalling Digital RID Plate Reader, distributed in 11 states. The recall was initiated on 9 Oct 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI 05051700000376

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-1055-2017
FDA event ID: 76043
Recalling firm: The Binding Site Group, Birmingham
Classification: Class II
Status: Terminated
Recall initiated: 9 Oct 2012
FDA classified: 19 Jan 2017
Reported: 25 Jan 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

9 Oct 2012	Recall initiated by company
19 Jan 2017	Classified by FDA	+1563 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

If a control ring is marked after reading, the software will not flag results that are out of the specified QC range.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Digital RID Plate Reader and Software Product Code: AD400

Where it was distributed

U.S. distribution to the following; MA, GA, NY, IA, CA, IL, UT, NJ, NC, MD, MN. Foreign distribution to the following; UK, Germany, Spain, France.

California Georgia Iowa Illinois Massachusetts Maryland Minnesota North Carolina New Jersey New York Utah

Questions about this recall

Is Digital RID Plate Reader recalled?

Yes. The Binding Site Group recalled Digital RID Plate Reader on 9 Oct 2012. The recall is Class II and its status is Terminated. Recall number Z-1055-2017.

Why was it recalled?

If a control ring is marked after reading, the software will not flag results that are out of the specified QC range.

Which lots are affected?

UDI 05051700000376

Where was it sold?

U.S. distribution to the following; MA, GA, NY, IA, CA, IL, UT, NJ, NC, MD, MN. Foreign distribution to the following; UK, Germany, Spain, France.

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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