Z-2362-2026Class II

Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version...

Name: Z-2362-2026 Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version...
Creator: The Binding Site Group, Ltd.
Published: 2026-04-16
License: https://open.fda.gov/license/

The Binding Site Group Ltd. / initiated 2026-04-16 / Open, Classified

FDA source

The Binding Site Group, Ltd. began a recall of 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... on 2026-04-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2362-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-16
Posted: 2026-06-09
Recalling firm: The Binding Site Group Ltd.
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 used in conjunction with the EXENT assays.
Product code: OTA Mass Spectrometer For Clinical Multiplex Test Systems
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.
FDA 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 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.
Quantity in commerce: 1
Distribution: US Nationwide distribution.
Product codes and lots: Lot Code: Model No; IE800A; EXENT Analyser; UDI; 05051700020886, Serial Number; 101150, Software version; v1.0.20.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2362-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2362-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-09

Product code OTA

K250159Class IIImmunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserThe Binding Site Group , Ltd. / cleared 2025-10-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)