Binding Site IgG4 Kit Recalled for Incorrect Product Insert Information
The Binding Site Group is recalling Optilite IgG4 Kits because the product insert does not reflect a change to the measuring range.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a documentation and labeling error regarding the measuring range, fitting the criteria for a Low severity score.
Plain-English summary
The Binding Site Group, Ltd. is recalling the Optilite IgG4 Kit (Product Code: LK009.OPT.A, Lot #401413) due to a labeling discrepancy. A change to the lower end of the measuring range was not reflected in the product insert. While the measuring range provided in the instrument parameters is correct, it contradicts the information provided in the product insert.
This recall affects 9 users in the United States. The product was distributed to facilities in Florida, Texas, Pennsylvania, California, Massachusetts, Washington, Michigan, and Connecticut. There is no foreign distribution.
Consumers and healthcare facilities should stop using the affected kits and contact The Binding Site Group, Ltd. for further instructions or replacement.
The recalled product
- Product
- Optilite IgG4 Kit Product Code: LK009.OPT.A
- Manufacturer
- The Binding Site Group, Ltd.
- Hazard
- Affected units
- 9
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #401413
Distribution
Related recalls
Same manufacturer · The Binding Site Group, Ltd.
See all →- HighEXENT Analyser marked plates as passed without performing quality control
FDA (Devices) · 2026-06-17
- HighFreelite Human Lambda Free Kit Recalled for Calibration Curve Inaccuracy
FDA (Devices) · 2021-12-01
- HighFREELITE Kappa Free Kit quality control bias recall
FDA (Devices) · 2021-07-14
- ModerateBinding Site recalls Optilite Freelite Mx Kappa Free Kits for quality control bias
FDA (Devices) · 2021-02-10
- HighBinding Site Recalls Optilite Rheumatoid Factor Kits Due to Calibrator Error
FDA (Devices) · 2020-06-03
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateBinding Site OPTILITE IgM Kit Recalled for Potential Calibration Issues
FDA (Devices) · 2020-02-26
- ModerateBinding Site IgG4 Kit Recalled for Inaccurate Results in High Levels
FDA (Devices) · 2017-02-01
- ModerateBinding Site IgG4 Reagent Kits Recalled for Inaccurate Results
FDA (Devices) · 2017-02-01
- ModerateOptilite Freelite Lambda Free Kit Recalled for Inaccurate Test Results
FDA (Devices) · 2017-01-25
- ModerateBinding Site Human IgG Subclass Kit Recalled for Inaccurate Results
FDA (Devices) · 2017-02-01
- ModerateBinding Site IgG Subclass Reagent Kits Recalled for Inaccurate Results
FDA (Devices) · 2017-02-01