Home / Recalls / The Binding Site Group, Ltd. / Z-2362-2026

Z-2362-2026 Class II Ongoing

Recalled by The Binding Site Group, Ltd. — Birmingham, N/A

Recall Details

Product Type
Devices
Report Date
June 17, 2026
Initiation Date
April 16, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1

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.

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 Pattern

US Nationwide distribution.

Code Information

Lot Code: Model No; IE800A; EXENT Analyser; UDI; 05051700020886, Serial Number; 101150, Software version; v1.0.20.

Other recalls by The Binding Site Group, Ltd.

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  • Z-2030-2021 Class II — FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie (May 20, 2021)
  • Z-0943-2021 Class II — Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A (November 18, 2020)
  • Z-2071-2020 Class II — The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700 (April 9, 2020)
  • Z-1500-2020 Class II — Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Prod (November 6, 2019)
  • Z-2110-2020 Class II — Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: (October 7, 2019)
  • Z-1327-2020 Class II — OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565 (July 29, 2019)
  • Z-1619-2020 Class II — C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)0 (April 25, 2019)
  • Z-0671-2020 Class II — Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein (February 19, 2019)
  • Z-0604-2019 Class II — Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of (November 6, 2018)