Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: ...
Reason for Recall / 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.
Product Description & Identification
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.
Affected Products
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Birmingham |
| State | N/A |
| Event id | 98830 |
| Address 1 | 8 Calthorpe Road |
| Address 2 | N/A |
| Code info | Lot Code: Model No; IE800A; EXENT Analyser; UDI; 05051700020886, Serial Number; 101150, Software version; v1.0.20. |
| Postal code | N/A |
| Report date | 20260617 |
| Product type | Devices |
| Product quantity | 1 |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260416 |
| Initial firm notification | Letter |
| Center classification date | 20260609 |
Overview
- Recalling FirmThe Binding Site Group, Ltd.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution.