FDA recall, , Moderate risk
EXENT Analyser
It was reported that plates 2 and 3 were marked as passed, although it appeared that QC had not been performed on these plates, despite samples being measured.
Summary by Recall Canary from the FDA notice
What happened
The Binding Site Group, Ltd., of Birmingham, United Kingdom, began a recall of the EXENT Analyser on April 16, 2026, after it was reported that plates 2 and 3 were marked as passed, although it appeared that QC had not been performed on these plates, despite samples being measured.
The potential clinical hazards include false or missed detection of M-protein (false positive) and falsely elevated or decreased M-protein concentration. The recall was added to the FDA's Enforcement Report and classified by the FDA on June 9, 2026, with US Nationwide distribution.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and lot code listed under your product.
EXENT Analyser
- Model number
- IE800.A
- Lot code
- IE800A
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- The Binding Site Group, Ltd.Birmingham, United Kingdom
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98830
- Recall number
- Z-2362-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
