Binding Site IgG4 Kit Recalled for Incorrect Product Insert Information
The Binding Site Group is recalling Optilite IgG4 Kits because the product insert does not reflect a change to the measuring range.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a documentation and labeling error regarding the measuring range, fitting the criteria for a Low severity score.
Plain-English summary
The Binding Site Group, Ltd. is recalling the Optilite IgG4 Kit (Product Code: LK009.OPT.A, Lot #401413) due to a labeling discrepancy. A change to the lower end of the measuring range was not reflected in the product insert. While the measuring range provided in the instrument parameters is correct, it contradicts the information provided in the product insert.
This recall affects 9 users in the United States. The product was distributed to facilities in Florida, Texas, Pennsylvania, California, Massachusetts, Washington, Michigan, and Connecticut. There is no foreign distribution.
Consumers and healthcare facilities should stop using the affected kits and contact The Binding Site Group, Ltd. for further instructions or replacement.
The recalled product
- Product
- Optilite IgG4 Kit Product Code: LK009.OPT.A
- Manufacturer
- The Binding Site Group, Ltd.
- Hazard
- Affected units
- 9
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)
- Lot #401413
Distribution
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