Lower riskMedical device recall · FDA · Published April 16, 2026
EXENT Analyser Software Version 1.0.20: False M-protein Results Risk
The Binding Site Group recalls EXENT Analyser software version 1.0.20 due to potential false M-protein results. Affected units may show inaccurate test results, requiring immediate verification with a different method.
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.
Take action
Contact the company
📍Recalling firmThe Binding Site Group, Ltd.8 Calthorpe Road · Birmingham, United Kingdom
“EXENT Analyser Software Version 1.0.20: False M-protein Results Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49460-exent-analyser-software-version-1-0-20-false-m-protein. Based on FDA recall #Z-2362-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2362-2026%22&limit=1).
The FDA announced on April 16, 2026, that The Binding Site Group, Ltd. is recalling the EXENT Analyser (Model IE800.A) due to quality control failures that may lead to false or missed detection of M-protein.
How to tell if you have it
Brand: EXENT Analyser
Model/Catalog Number: IE800.A
Software Version: 1.0.20
Lot Code: Model No; IE800A; EXENT Analyser; UDI; 05051700020886, Serial Number; 101150, Software version; v1.0.20
The hazard
The FDA stated that plates 2 and 3 were marked as passed despite quality control not being performed, posing potential clinical hazards including false positive detection or falsely elevated or decreased M-protein concentration.
Context
GovInfoNow's records show The Binding Site Group, Ltd. has 15 other recalls on record since August 23, 2017. Other recent recalls of similar products include Freelite Human Lambda Free Kit Recall (October 15, 2021), FREELITE Human Kappa Free Kit recall (May 20, 2021), and Optil: Freelite Mx Kappa Free Kit recall (November 18, 2020). Vivoo Protein Test Recall occurred on November 22, 2025, and Exploro Fertility Test Recall also occurred on November 22, 2025. TECHNO-PATH Multichem ID-B Serum Recall was reported on October 17, 2025.
How to tell if you have this one
Check for software version 1.0.20 on the EXENT Analyser. The model number is IE800.A and it was sold with lot code 05051700020886.
Brand
The Binding Site Group
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on your EXENT Analyser; if it is 1.0.20, it is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2362-2026 (April 16, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2362-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.