The Binding Site Group, Ltd. recalls

28 recalls on record · latest: October 15, 2021

Official U.S. recall history for The Binding Site Group, Ltd., compiled from official government records.

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The Binding Site Group, Ltd. recalls Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAP…

October 15, 2021 · Medical device recalls Moderate risk Due to calibration curves producing a higher activity than routinely expected a…

The Binding Site Group, Ltd. recalls FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas…

May 20, 2021 · Medical device recalls Moderate risk The high and low level "Quality Controls" demonstrate a positive bias of approx…

The Binding Site Group, Ltd. recalls Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A

November 18, 2020 · Medical device recalls Moderate risk Due to customer complaints of positive bias impacting quality control. The high…

The Binding Site Group, Ltd. recalls The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Cl…

April 9, 2020 · Medical device recalls Moderate risk A software issue that may affect the analyzer's result accuracy.

The Binding Site Group, Ltd. recalls Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018…

November 6, 2019 · Medical device recalls Moderate risk It has been identified that the rheumatoid factor (RF) calibrator values over r…

The Binding Site Group, Ltd. recalls Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four c…

October 7, 2019 · Medical device recalls Moderate risk Assigned Rheumatoid Factor (RF) calibrator value for calibrator component inclu…

The Binding Site Group, Ltd. recalls OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565

July 29, 2019 · Medical device recalls Moderate risk There is a potential that users may experience difficulty validating the calibr…

The Binding Site Group, Ltd. recalls C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,

April 25, 2019 · Medical device recalls Moderate risk A reagent in C reactive protein kits is not performing to specification and sam…

The Binding Site Group, Ltd. recalls Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitati…

February 19, 2019 · Medical device recalls Moderate risk Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protei…

The Binding Site Group, Ltd. recalls Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum…

November 6, 2018 · Medical device recalls Moderate risk Firm is offering advice to customers experiencing challenges when validating th…

The Binding Site Group, Ltd. recalls VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK01…

August 12, 2018 · Medical device recalls Moderate risk A deterioration of performance was identified with influenza type B Enzyme Immu…

The Binding Site Group, Ltd. recalls Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum…

July 25, 2018 · Medical device recalls Moderate risk After running the calibration curve, the recovery of the IgM kit control result…

The Binding Site Group, Ltd. recalls Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding…

March 9, 2018 · Medical device recalls Moderate risk The product is not meeting the antigen excess protection claim of up to 760mg/L…

The Binding Site Group, Ltd. recalls Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of…

January 4, 2018 · Medical device recalls Moderate risk The low and high controls for the product are returning results above the assig…

The Binding Site Group, Ltd. recalls Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The Bind…

August 23, 2017 · Medical device recalls Moderate risk The high control for the kit is recovering low and may be out of range for assi…

The Binding Site Group, Ltd. recalls Optilite IgG4 Kit Product Code: LK009.OPT.A

December 23, 2016 · Medical device recalls A change to the lower end of the measuring range and product insert did not ref…

The Binding Site Group, Ltd. recalls Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and moni…

October 28, 2016 · Medical device recalls Moderate risk A change in the calibration curve causing an increase in false prozone flags.

The Binding Site Group, Ltd. recalls Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.

July 5, 2016 · Medical device recalls Moderate risk Batch numbers listed are reporting Lambda Free Light Chain results >114mg/L tha…

The Binding Site Group, Ltd. recalls Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko Clinical Chemistry Analyzer is a ful…

May 13, 2015 · Medical device recalls Moderate risk Potential risk of the Optilite lid/cover falling suddenly and causing injury wh…

The Binding Site Group, Ltd. recalls Human lgG4 Subclass kit for use on the Beckman Coulter AU" series This kit is intended for qualifying human IgG subclas…

September 11, 2014 · Medical device recalls Moderate risk Customer complaints identified that samples containing extremely high IgG4 leve…

The Binding Site Group, Ltd. recalls Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex reagent and lgG Antisera for use on H…

September 11, 2014 · Medical device recalls Moderate risk Customer complaints identified that samples containing extremely high IgG4 leve…

The Binding Site Group, Ltd. recalls MininephThl Human lgG4 Kit Product Code: ZK009.LR This kit is intended for qualifying human IgG subclasses 1,2,3 and 4…

September 11, 2014 · Medical device recalls Moderate risk Customer complaints identified that samples containing extremely high IgG4 leve…

The Binding Site Group, Ltd. recalls Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Product Code LK009.IM This kit is intended for qu…

September 11, 2014 · Medical device recalls Moderate risk Customer complaints identified that samples containing extremely high IgG4 leve…

The Binding Site Group, Ltd. recalls Human lgG4 Subclass Liquid Reagent Kits For use on the Roche Cobas"6000 This kit is intended for qualifying human IgG s…

September 11, 2014 · Medical device recalls Moderate risk Customer complaints identified that samples containing extremely high IgG4 leve…

The Binding Site Group, Ltd. recalls Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II Analyser Product Code: NK009.T This kit is intende…

September 11, 2014 · Medical device recalls Moderate risk Customer complaints identified that samples containing extremely high IgG4 leve…

The Binding Site Group, Ltd. recalls Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ Analyser Product Code: NK001.T This kit is intended…

September 11, 2014 · Medical device recalls Moderate risk Customer complaints identified that samples containing extremely high IgG4 leve…

The Binding Site Group, Ltd. recalls Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma a…

November 28, 2012 · Medical device recalls Moderate risk Calibration curve activity has increased over time in the kit lots listed.

The Binding Site Group, Ltd. recalls Digital RID Plate Reader and Software Product Code: AD400

October 9, 2012 · Medical device recalls Moderate risk If a control ring is marked after reading, the software will not flag results t…