Binding Site C-Reactive Protein Kit Recalled for Reagent Performance Issues
The Binding Site Group is recalling C-Reactive Protein Kits because a reagent is not performing to specification, potentially affecting low-concentration samples.
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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
The Binding Site Group, Ltd. is recalling C-Reactive Protein Kits (REF NK044.S.A) intended for use on the SPAplus analyzer. The recall is limited to Lot 455672, which was distributed in Florida.
The recall was initiated because a reagent in the kits is not performing to specification. This defect may affect samples with known concentrations less than or equal to 10 mg/L. The product is prescription-only.
Healthcare facilities and laboratories that have received this specific lot should stop using the kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,
- Manufacturer
- The Binding Site Group, Ltd.
- Hazard
- Affected units
- 1
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 455672
Distribution
Distributed in 1 state:
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