PlainRecalls
FDA Devices Moderate Class II Terminated

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 Opti

Reported: December 18, 2019 Initiated: February 19, 2019 #Z-0671-2020

Product Description

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.

Reason for Recall

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

Details

Units Affected
10 kits
Distribution
US Nationwide distribution in the states of CA and GA. OUS not provided due to product being manufacture OUS
Location
Birmingham, N/A

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by The Binding Site Group, Ltd.. Units affected: 10 kits.
Why was this product recalled? ▼
Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 18, 2019. Severity: Moderate. Recall number: Z-0671-2020.

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