Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United KingdomLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Thermo Fisher ScientificLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list The Binding Site Group with 44 510(k) clearances and 29 device recalls. The most recent is a device recall dated Apr 16, 2026: Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A ….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 16, 2026 | Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The Class II · It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on thes | Device recalls |
| Oct 17, 2025 | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserK250159 · SGG | 510(k) clearances |
| May 23, 2025 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitK250549 · DFH | 510(k) clearances |
| Oct 15, 2021 | 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 LK018Class II · Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separa | Device recalls |
| May 20, 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: LK01Class II · The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values | Device recalls |
| Nov 18, 2020 | Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.AClass II · Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstratin | Device recalls |
| Apr 9, 2020 | The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Clinical Chemistry AnalClass II · A software issue that may affect the analyzer's result accuracy. | Device recalls |
| Nov 6, 2019 | Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319Class II · It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference mat | Device recalls |
| Oct 7, 2019 | Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)Class II · Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to aid in the diagnosis o | Device recalls |
| Sep 4, 2019 | Human IgA liquid reagent kit for Use on SPAPlusK192116 · CFN | 510(k) clearances |
| Aug 19, 2019 | Optilite IgA KitK191985 · CFN | 510(k) clearances |
| Jul 15, 2019 | Optilite IgM KitK191635 · CFN | 510(k) clearances |
| Jun 27, 2019 | Human IgM Kit for use on SPAPlusK191465 · CFN | 510(k) clearances |
| May 28, 2019 | Optilite IgM CSF KitK190686 · CFN | 510(k) clearances |
| Apr 25, 2019 | C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,Class II · A reagent in C reactive protein kits is not performing to specification and samples with known concentrations less-than- | Device recalls |
| Jan 23, 2019 | Optilite IgA CSF KitK183151 · CFN | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
