Binding Site IgG4 Kit Recalled for Inaccurate Results in High Levels
The Binding Site Group is recalling MininephThl Human IgG4 Kits because samples with extremely high IgG4 levels may yield 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 moderate severity.
Plain-English summary
The Binding Site Group, Ltd. is recalling the MininephThl Human IgG4 Kit (Product Code: ZK009.LR) due to customer complaints regarding test accuracy. The kit is intended for the quantitative measurement of human IgG subclasses 1, 2, 3, and 4 immunoglobulins in serum using the Beckman Coulter AU series. These measurements are used in the diagnosis of abnormal protein metabolism and the body's ability to resist infectious agents.
The recall was initiated because samples containing extremely high IgG4 levels exhibit antigen excess, which causes the kit to yield spuriously low IgG4 results. This issue affects all lots of the product. 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, the Czech Republic, Belgium, Italy, Australia, Brazil, Chile, China, Costa Rica, Kuwait, New Zealand, Oman, Pakistan, Portugal, Sweden, Taiwan, and Turkey.
Healthcare providers and laboratories should stop using the affected kits and contact The Binding Site Group, Ltd. for further instructions on returns or replacements. Patients who have had IgG4 tests performed using this kit should consult their healthcare provider to discuss the potential impact of inaccurate results on their diagnosis or treatment.
The recalled product
- Product
- MininephThl Human lgG4 Kit Product Code: ZK009.LR 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 metabolism and
- 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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