medical Class II Updated 2019-12-18

The Binding Site Group, Ltd. recalls Optilite C-Reactive Protein Kit - Product Usage: The Optilit

Recalled 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 evaluation of the amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings. The Optilite C-Reactive Protein Calibrator is intended for the calibration of the Optilite C-Reactive Protein Reagent on the Optilite analyser. The Optilite C-Reactive Protein Controls are intended for use in quality control by monitoring accuracy and precision for the Optilite C-Reactive Protein Reagent.


Hazard / Issue

Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model Number: NK044.OPT.A Lot 437705 UDI 05051700018449 Medical Device Listing number D317086
View official government recall

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