[pending] Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Ve
Pending LLM rewrite. Source: FDA_DEVICE Z-2362-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
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
- Manufacturer
- The Binding Site Group, Ltd.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lot Code: Model No
- IE800A
- EXENT Analyser
- UDI
- 05051700020886
- Serial Number
- 101150
- Software version
- v1.0.20.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereFletcher CT/MR Shielded Applicator Set for Gynecological Brachytherapy Recalled
FDA (Devices) · 2026-07-15
- HighVITEK 2 AST-N447 Test Kit Potentially Returns False Resistant Results
FDA (Devices) · 2026-07-15
- SevereTMINI Tracking Array knob loosening causing potential array misalignment
FDA (Devices) · 2026-07-15
- ModerateVersius Surgical System Console affected by cybersecurity vulnerability
FDA (Devices) · 2026-07-15
- SevereBrachytherapy Applicator Advanced Gynecological Applicator Tip Detachment
FDA (Devices) · 2026-07-15