Recall Z-2362-2026 ยท OTA Mass Spectrometer For Clinical Multiplex Test Systems
The Binding Site Group, Ltd.
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.
| Date | Jun 9, 2026 (initiated Apr 16, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | Firm notified customers via "Urgent Medical Device Correction" letter dated April 14, 2026. Customers were advised to confirm QC results are present in the QC results screen for the corresponding plate barcode after the completion of each plate measurement. If no QC result is displayed, do not release results from that plate and repeat the run ensuring QC material is properly loaded. The customer should also contact US Technical Support. When performing multi-plate runs while loading a previously used QC vials, ensure newly opened QCs are loaded onto Reagent Runner 2 as well, or discard and |
| Quantity | 1 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K250159 | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser The Binding Site Group , Ltd., Oct 17, 2025 |