Binding Site Human IgG Subclass Kit Recalled for Inaccurate Results
The Binding Site Group is recalling Human IgG Subclass Kits because they may produce falsely low results for patients with extremely high IgG4 levels.
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 moderate severity.
Plain-English summary
The Binding Site Group, Ltd. is recalling Human IgG Subclass Kits (Product Code LK009.IM) intended for use on the Beckman IMMAGE/IMMAGE 800 Analyser. The recall affects all lots of the product. This kit is used to measure human IgG subclasses 1, 2, 3, and 4 in serum to help diagnose abnormal protein metabolism and immune system deficiencies.
Customer complaints identified that the kit exhibits antigen excess when testing samples with extremely high IgG4 levels. This condition causes the kit to yield spuriously low IgG4 results, which could lead to incorrect clinical interpretations. The product was distributed worldwide, including in the United States and various international locations.
Healthcare facilities and laboratories should stop using the affected kits and contact The Binding Site Group, Ltd. for instructions on returning the product or obtaining replacements.
The recalled product
- Product
- Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Product Code LK009.IM 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
- 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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