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Recall Canary
EXENT Analyser
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MEDICAL DEVICE RECALLMODERATE

EXENT Analyser

The Binding Site is recalling the EXENT Analyser due to a software error that may cause inaccurate M-protein detection or measurements.

What to do

Contact your local Binding Site representative for assistance with software updates and to discuss the impact on previously processed samples.

Recalled
Listed
Updated
Recall No.
Z-2362-2026
Agency
FDA
Firm
The Binding Site Group, Ltd.
Recall ID
98830
Status
ONGOING

Why it was recalled

The Binding Site is recalling the EXENT Analyser due to a software error where plates 2 and 3 were incorrectly marked as passed without undergoing quality control. This failure may result in false or missed detection of M-protein or inaccurate concentration measurements.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

EXENT Analyser

UDI-DI
05051700020886
Model/Catalog number
IE800.A
Software version
1.0.20

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Device Defect recalls

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification