Binding Site Recalls Optilite C-Reactive Protein Kits Due to Deterioration
The Binding Site Group is recalling 10 Optilite C-Reactive Protein Kits because the reagent has deteriorated. The kits were distributed in California and Georgia.
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. The source text does not report any hospitalizations, serious injuries, or deaths, and the hazard is limited to reagent deterioration without reported adverse health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
The Binding Site Group, Ltd. is recalling 10 units of the Optilite C-Reactive Protein Kit. The recall is due to the deterioration of the C-reactive protein (CRP) reagent contained in the kits. The product is intended for the quantitative in vitro determination of CRP concentration in serum using the Binding Site Optilite analyser.
The affected product is identified by Model Number NK044.OPT.A, Lot 437705, UDI 05051700018449, and Medical Device Listing number D317086. The recall covers 10 kits that were distributed in the United States, specifically in the states of California and Georgia.
This recall is classified as Class II by the U.S. Food and Drug Administration. The source text does not report any specific illnesses or injuries associated with the use of these kits. Users of the affected product should stop using the kits and contact the manufacturer for further instructions.
The recalled product
- Product
- Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in…
- Manufacturer
- The Binding Site Group, Ltd.
- Hazard
- Affected units
- 10
Distribution
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