Binding Site OPTILITE IgM Kit Recalled for Potential Calibration Issues
The Binding Site Group is recalling OPTILITE IgM Kits due to potential calibration difficulties that may cause false patient results and testing delays.
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. The hazard involves potential false results and testing delays rather than direct physical injury or death, fitting the criteria for a moderate severity recall.
Plain-English summary
The Binding Site Group, Ltd. is recalling 3,294 units of the OPTILITE IgM Kit (REF: NK012.OPT.A, UDI: 05051700017565). The recall affects Lot # 422251. The product was distributed to facilities in California, Pennsylvania, Florida, Arkansas, South Dakota, Massachusetts, West Virginia, Alabama, Georgia, Illinois, Minnesota, Maryland, Arizona, North Carolina, Tennessee, Washington, Michigan, New York, Kentucky, South Carolina, Indiana, Oregon, Nebraska, Ohio, Texas, Vermont, Utah, and Iowa.
The recall was initiated because users may experience difficulty validating the calibration of the kit. This issue is indicated by kit control values reporting outside of the specified ranges. If this occurs, it could result in potential false patient results, which may cause a delay in care until repeat testing is performed.
Healthcare facilities and users should stop using the affected kits and contact The Binding Site Group, Ltd. for instructions on how to return or dispose of the product.
The recalled product
- Product
- OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
- Manufacturer
- The Binding Site Group, Ltd.
- Affected units
- 3,294
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 # 422251
Distribution
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