The Binding Site EXENT Analyser recalled for quality control bypass risk affecting M-protein test results
What this means
The EXENT Analyser, an automated blood-test device, has a software issue where certain test plates were marked as passed without performing required quality checks. This could allow inaccurate M-protein measurements—either missed detections or wrong concentration values—to be reported to clinicians.
- If you operate an EXENT Analyser (Model IE800.A, Software v1.0.20), contact The Binding Site Group, Ltd. for guidance immediately.
- Review recent test results from plates 2 and 3 for any M-protein measurements that may need rechecking.
- Do not rely on QC pass indicators for affected plates until the device is repaired or updated.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2362-2026Want us to check the next one for you?
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