Birmingham, N/A, United Kingdom
The Binding Site Group, Ltd. recalls
15 recalls recorded since 2018, most recently on 16 April 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls15
Ongoing (FDA)1
Terminated or completed14
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 16 April 2026
- 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 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2362-2026
- 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 quantit
Terminated Class II Medical devices
- Recall started
- 15 October 2021
- Terminated
- 4 February 2025
- Reason
- Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and calibrator point 6, which can be exacerbated with calibrator 6 activity reaches the optical ceiling of the SPA+ analyzer.
- Distribution
- U.S.: CA, CO, FL, IL, IN, KY, LA, MI, NY, OK, SD, TX and VA. O.U.S.: Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0274-2022
- Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S
Terminated Class II Medical devices
- Recall started
- 20 May 2021
- Terminated
- 4 February 2025
- Reason
- The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA, GA, FL, MA, MO, MI, WA, NY, PA, MN, AL, MD, OK, NE, IN, ID, OH, TX, HI, DC and the countries of Canada, Australia, Austria, Belgium, Bulgaria, Canada, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Italy, Luxembou
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2030-2021
- FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK016.CB, IVD CE, UDI: 05051700012096
Terminated Class II Medical devices
- Recall started
- 18 November 2020
- Terminated
- 23 December 2024
- Reason
- Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstrating a positive bias compared to assigned values.
- Distribution
- U.S.: CO, FL, IA, MA, NC, NJ, NY, OH, SD, and UT. O.U.S.: Not provided
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0943-2021
- Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
Terminated Class II Medical devices
- Recall started
- 9 April 2020
- Terminated
- 19 August 2022
- Reason
- A software issue that may affect the analyzer's result accuracy.
- Distribution
- US Nationwide distribution including in the states of AL, AR, CA, FL, IL, IN, KS, KY, MA, MN, NC, NE, OH, PA, TX and VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2071-2020
- The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of an
Terminated Class II Medical devices
- Recall started
- 6 November 2019
- Terminated
- 8 September 2022
- Reason
- It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference material RF serum. This could result in reporting falsely abnormal results which may lead to unnecessary additional serological testing.
- Distribution
- Distributed in CA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1500-2020
- Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319
Terminated Class II Medical devices
- Recall started
- 7 October 2019
- Terminated
- 11 January 2022
- Reason
- Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to aid in the diagnosis of rheumatoid arthritis over recovers by 7% in comparison to the reference material RF serum. This could result in reporting abnormal (false positive) results, which may lead to unnecessary additional serological testing and a delay in treatment.
- Distribution
- US: AL, AR, AZ, FL, GA, KY, MA, MD, MI, MN, MS, NC, NE, NY, OR, PA, TX, VT, WA, WI OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2110-2020
- Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
Terminated Class II Medical devices
- Recall started
- 29 July 2019
- Terminated
- 13 January 2022
- Reason
- There is a potential that users may experience difficulty validating the calibration of the kit. This is indicated by kit control values reporting outside the specified ranges. This could result in potential false patient results which could cause a delay until repeat testing is performed.
- Distribution
- CA, PA, FL, AR, SD, MA, WV, AL, GA, IL, MN, MD, AZ, NC, TN, WA, MI, NY, KY, SC, IN, OR, NE, OH, TX, VT, WA, UT, IA,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1327-2020
- OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
Terminated Class II Medical devices
- Recall started
- 25 April 2019
- Terminated
- 27 April 2021
- Reason
- A reagent in C reactive protein kits is not performing to specification and samples with known concentrations less-than-or-equal to 10 mg/L may be affected
- Distribution
- U.S.: FL
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1619-2020
- C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,
Terminated Class II Medical devices
- Recall started
- 19 February 2019
- Terminated
- 27 April 2021
- Reason
- Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits
- Distribution
- US Nationwide distribution in the states of CA and GA. OUS not provided due to product being manufacture OUS
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0671-2020
- Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site O
Terminated Class II Medical devices
- Recall started
- 6 November 2018
- Terminated
- 27 April 2021
- Reason
- Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This is indicated by kit control values reporting outside the specified ranges.
- Distribution
- U.S Distribution to states of: CA, IL, PA, FL, NE, WA, IN, NY, SD and VA,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0604-2019
- Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human ser
Terminated Class II Medical devices
- Recall started
- 12 August 2018
- Terminated
- 20 January 2022
- Reason
- A deterioration of performance was identified with influenza type B Enzyme Immunoassay Kits with findings of a positive bias with kit controls. Patient sample results may be affected with falsely elevated results incorrectly indicating a protective level of anti-Hib antibody in the assessment of immunodeficiency.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of M.A., C.A., MO., NC, MN, VA, WA, and IL and country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1469-2020
- VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage: This assay is designed for the in vitro measurement of specific IgG antibodies aga
Terminated Class II Medical devices
- Recall started
- 25 July 2018
- Terminated
- 27 April 2021
- Reason
- After running the calibration curve, the recovery of the IgM kit control results decrease demonstrating a reduction in accuracy within the same day; control results may be out of range one day after running the assay calibration curve. Samples have been shown to be similarly affected.
- Distribution
- U.S.: IL, WV, NE, SD, NY, IN, WA, MD, NJ, PA, NC, AR, FL, VA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0477-2019
- Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human ser
Terminated Class II Medical devices
- Recall started
- 9 March 2018
- Terminated
- 22 June 2020
- Reason
- The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.
- Distribution
- US Distribution was made to CA. There was no foreign/military/government distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1301-2018
- Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K. The Optilite Beta-2-Microglobulin (¿2M) Urine kit is intended
Terminated Class II Medical devices
- Recall started
- 4 January 2018
- Terminated
- 9 June 2020
- Reason
- The low and high controls for the product are returning results above the assigned values.
- Distribution
- US Distribution was made to CA. There was no foreign/military/government distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0553-2018
- Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid fac
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.