Binding Site IgG4 Reagent Kits Recalled for Inaccurate Results
The Binding Site Group is recalling Human IgG4 Subclass Liquid Reagent Kits because they may yield spuriously low results for samples with extremely high IgG4 levels.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves inaccurate diagnostic results (spuriously low IgG4) rather than direct physical injury or a high-risk pathogen, fitting the criteria for a moderate severity recall involving potential adverse health consequences through misdiagnosis.
Plain-English summary
The Binding Site Group, Ltd. is recalling Human IgG4 Subclass Liquid Reagent Kits (Product Code LK009.H/LK001.H) and related antisera and latex reagents. These products are intended for use on Hitachi 911/912/917 and Hitachi Modular P analyzers to quantify human IgG subclasses 1, 2, 3, and 4 in serum. The recall covers all lots of the affected products.
The recall was initiated after customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess. This condition causes the kits to yield spuriously low IgG4 results, which could lead to inaccurate diagnostic information regarding abnormal protein metabolism or immune response.
The affected products were distributed worldwide, including in the United States (Florida, Ohio, Tennessee, Minnesota, New Mexico, Michigan, and California) and internationally to Canada, France, the UK, Spain, Germany, and other countries. Users of these reagent kits should stop using the affected lots and contact The Binding Site Group, Ltd. for further instructions or replacement.
The recalled product
- Product
- 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 Modular P Product Code LK009.H/LK001.H This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins…
- Manufacturer
- The Binding Site Group, Ltd.
- Hazard
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)
- All lots.
Distribution
Part of a larger recall action
This product is one of 7 recalled by The Binding Site Group, Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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