PlainRecalls

The Binding Site Group, Ltd.

Compiled from official public sources by the editorial team.

28 recalls on record · Latest: Dec 1, 2021

The Binding Site Group, Ltd. Recall Insight

The Binding Site Group, Ltd. appears on 28 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.028% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Dec 1, 2021, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 28 entries, severity tagging shows 0 critical, 27 moderate, and 1 lower-severity recalls. Affected-unit counts are disclosed on 26 of 28 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (28). The date window on this page runs from Jan 25, 2017 to Dec 1, 2021.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Dec 1, 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 LK018.10S

FDA Devices Moderate Jul 14, 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…

FDA Devices Moderate Feb 10, 2021

Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A

FDA Devices Moderate Jun 3, 2020

Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)

FDA Devices Moderate May 27, 2020

The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Clinical Chemistry Analyzer is a…

FDA Devices Moderate Apr 8, 2020

C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,

FDA Devices Moderate Mar 25, 2020

Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319

FDA Devices Moderate Mar 18, 2020

VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage: This assay …

FDA Devices Moderate Feb 26, 2020

OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565

FDA Devices Moderate Dec 18, 2019

Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C…

FDA Devices Moderate Dec 19, 2018

Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two c…

FDA Devices Moderate Nov 28, 2018

Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two c…

FDA Devices Moderate Apr 11, 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,…

FDA Devices Moderate Feb 14, 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…

FDA Devices Moderate Oct 11, 2017

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

FDA Devices Moderate Feb 1, 2017

Human lgG4 Subclass kit for use on the Beckman Coulter AU" series This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobul…

FDA Devices Moderate Feb 1, 2017

Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex reagent and lgG Antisera for use on Hitachi 911/912/917 and Hitachi…

FDA Devices Moderate Feb 1, 2017

MininephThl Human lgG4 Kit Product Code: ZK009.LR This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in …

FDA Devices Moderate Feb 1, 2017

Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Product Code LK009.IM This kit is intended for qualifying human IgG subclass…

FDA Devices Moderate Feb 1, 2017

Human lgG4 Subclass Liquid Reagent Kits For use on the Roche Cobas"6000 This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 …

FDA Devices Moderate Feb 1, 2017

Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II Analyser Product Code: NK009.T This kit is intended for qualifying…

FDA Devices Low Feb 1, 2017

Optilite IgG4 Kit Product Code: LK009.OPT.A

FDA Devices Moderate Feb 1, 2017

Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ Analyser Product Code: NK001.T This kit is intended for quali…

FDA Devices Moderate Jan 25, 2017

Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.

FDA Devices Moderate Jan 25, 2017

Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access…

FDA Devices Moderate Jan 25, 2017

Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.

FDA Devices Moderate Jan 25, 2017

Digital RID Plate Reader and Software Product Code: AD400

FDA Devices Moderate Jan 25, 2017

Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma…

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.