The Binding Site EXENT Analyser recalled for quality control bypass risk affecting M-protein test results
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.
From the FDA notice · Read the official notice ↗
What to do
- 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.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction with the EXENT assays.
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 1
- Illnesses reported
- None reported
- Manufactured in
- 8 Calthorpe Road, N/A, Birmingham, N/A, United Kingdom
- Classification
- Class II
- Recall number
- Z-2362-2026
In the FDA's words
- Description
- Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction with the EXENT assays. 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. Lot Code: Model No; IE800A; EXENT Analyser; UDI; 05051700020886, Serial Number; 101150, Software version; v1.0.20. Distribution: US Nationwide distribution. Affected quantity: 1
- Hazard
- 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.