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The Binding Site Group, Ltd.

16 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Soft recall (Z-2362-2026)The Binding Site Group, Ltd.2026-06-09
C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018 recall (Z-1619-2020)The Binding Site Group, Ltd.2020-03-31
Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent i recall (Z-0671-2020)The Binding Site Group, Ltd.2019-12-12
Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buf recall (Z-0604-2019)The Binding Site Group, Ltd.2018-12-13
Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buf recall (Z-0477-2019)The Binding Site Group, Ltd.2018-11-17
Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Product Code LK009.I recall (Z-1067-2017)The Binding Site Group, Ltd.2017-01-23
Human lgG4 Subclass kit for use on the Beckman Coulter AU" series This kit is intended for recall (Z-1068-2017)The Binding Site Group, Ltd.2017-01-23
Human lgG4 Subclass Liquid Reagent Kits For use on the Roche Cobas"6000 This kit is intend recall (Z-1069-2017)The Binding Site Group, Ltd.2017-01-23
Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex reagent recall (Z-1070-2017)The Binding Site Group, Ltd.2017-01-23
Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II Analyser Product Code recall (Z-1071-2017)The Binding Site Group, Ltd.2017-01-23
Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ Analyser Product Code: recall (Z-1072-2017)The Binding Site Group, Ltd.2017-01-23
MininephThl Human lgG4 Kit Product Code: ZK009.LR This kit is intended for qualifying huma recall (Z-1073-2017)The Binding Site Group, Ltd.2017-01-23
Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and mon recall (Z-1050-2017)The Binding Site Group, Ltd.2017-01-19
Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelit recall (Z-1053-2017)The Binding Site Group, Ltd.2017-01-19
Digital RID Plate Reader and Software Product Code: AD400 recall (Z-1055-2017)The Binding Site Group, Ltd.2017-01-19
Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit recall (Z-1043-2017)The Binding Site Group, Ltd.2017-01-18

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Every clearance here is in the API, with alerts when new ones post.