Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Produ
Summary
The FDA issued a Class II for Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: by The Binding Site Group, Ltd.. 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 bein.
Details
Source
Device Recall
External ID
Z-2362-2026
Action Date
2026-06-17
Status
Ongoing
Category
device
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.
Lot/Code Info: Lot Code: Model No; IE800A; EXENT Analyser; UDI; 05051700020886, Serial Number; 101150, Software version; v1.0.20.
Quantity Affected: 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.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-16
Company
Birmingham, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 228 device recalls issued in the same week, part of 403 device-related FDA actions this month.
The Binding Site Group, Ltd. has 5 FDA actions in our database, including 3 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (The Binding Site Group, Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does The Binding Site Group, Ltd. have FDA actions?
The Binding Site Group, Ltd. has 5 FDA actions in our database, including 3 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2362-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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