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, but the hazard involves inaccurate diagnostic results rather than direct physical injury or contamination, fitting the criteria for moderate severity.
Plain-English summary
The Binding Site Group, Ltd. is recalling Human IgG4 Subclass Liquid Reagent Kits (Product Code: NK009.T) intended for use on the Siemens BN"II Analyser. The recall covers all lots of the product.
Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess, which causes the kits to yield spuriously low IgG4 results. This inaccuracy may affect the diagnosis of abnormal protein metabolism and the body's ability to resist infectious agents.
The product was 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, the Czech Republic, Belgium, Italy, Australia, Brazil, Chile, China, Costa Rica, Kuwait, New Zealand, Oman, Pakistan, Portugal, Sweden, Taiwan, and Turkey. Users should stop using the affected kits and contact the manufacturer for instructions.
The recalled product
- Product
- Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II Analyser Product Code: NK009.T This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these 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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