Brand Name: EXENT Analyser recallZ-2362-2026 · The Binding Site Group, Ltd. · initiated Apr 16, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from The Binding Site Group, Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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 load newly opened QC vials into Reagent Runner 1. Retrospective review of previously released results is not considered necessary by the recalling firm. Please maintain awareness of the issue until Thermo Fisher Scientific identifies and implements a software enhancement that addresses the issue.
Recall details
- Recall number
- Z-2362-2026
- Status
- Open, Classified
- Initiated by the company
- Apr 16, 2026
- Posted by the FDA
- Jun 9, 2026
- Recalling firm
- The Binding Site Group, Ltd.
- Quantity
- 1
- Product code
- OTA
- FDA submissions
- K250159
- Distribution
- US Nationwide distribution.
Product 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.
Code information (models, lots, serial numbers)
Lot Code: Model No; IE800A; EXENT Analyser; UDI; 05051700020886, Serial Number; 101150, Software version; v1.0.20.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EXENT® Analyser IE800.AThe Binding Site Group Limited · Mass Spectrometer For Clinical Multiplex Test Systems1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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