CLASS II ONGOING Device recall · Reported 17 Jun 2026 · FDA Enforcement Report
Exent Analyser recalled by The Binding Site Group
The Binding Site Group is recalling Exent Analyser, distributed nationwide in the US. The recall was initiated on 16 Apr 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2362-2026
- FDA event ID
- 98830
- Recalling firm
- The Binding Site Group, Birmingham, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Apr 2026
- FDA classified
- 9 Jun 2026
- Reported
- 17 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 16 Apr 2026 | Recall initiated by company | |
| 9 Jun 2026 | Classified by FDA | +54 days |
| 17 Jun 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Exent Analyser recalled?
Yes. The Binding Site Group recalled Exent Analyser on 16 Apr 2026. The recall is Class II and its status is Ongoing. Recall number Z-2362-2026.
Why was it 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.
Which lots are affected?
Lot Code: Model No; IE800A; EXENT Analyser; UDI; 05051700020886, Serial Number; 101150, Software version; v1.0.20.
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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