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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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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