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.
The Binding Site Group recalls EXENT Analyser software version 1.0.20 because it may produce false or missed M-protein results. This could lead to incorrect diagnoses or treatment decisions for blood disorders.
The software may show plates as 'passed' without proper quality control checks. This can cause false positive or false negative results for M-protein, leading to incorrect test outcomes.
Users of the EXENT Analyser software version 1.0.20 for blood tests are affected. Patients with blood disorders requiring M-protein monitoring are most at risk.
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.
Verify the software version on your EXENT Analyser; if it is 1.0.20, it is affected.
The software may produce false or missed M-protein results, which could lead to incorrect diagnoses or treatment decisions.
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.
No, but you should verify results with a different method if you have a blood disorder requiring M-protein monitoring.
We’ve drafted a message you can send The Binding Site Group to request your refund or repair — edit it as you like.
Subject: Recall Z-2362-2026 — The Binding Site Group The Binding Site Group Hello, I own a The Binding Site Group that is covered by recall Z-2362-2026 from The Binding Site Group. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
