Binding Site IgG4 Subclass Kit Recalled for Inaccurate Results
The Binding Site Group is recalling Human IgG4 Subclass kits because high IgG4 levels can cause spuriously low results.
What this means for you
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, and the hazard involves inaccurate diagnostic results rather than direct physical injury or contamination, fitting the criteria for a moderate severity recall.
Plain-English summary
The Binding Site Group, Ltd. is recalling Human IgG4 Subclass kits intended for use on the Beckman Coulter AU series. The recall was initiated after customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess, which results in spuriously low IgG4 measurements.
The affected product is used to quantify human IgG subclasses 1, 2, 3, and 4 immunoglobulins in serum for the diagnosis of abnormal protein metabolism and immune response issues. The recall includes all lots of the product, which was distributed worldwide, including in the United States and various international locations.
Healthcare providers and laboratories should stop using the affected kits and contact The Binding Site Group, Ltd. for further instructions on handling the product.
The recalled product
- Product
- 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 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabol
- 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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