Device 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.
Z-0671-2020
Product summary
- Event
- Event 84243
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 kits
- Official record key
device-enforcement:Z-0671-2020
Official wording
Reason: Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits
Code information: Model Number: NK044.OPT.A Lot 437705 UDI 05051700018449 Medical Device Listing number D317086
Distribution pattern: US Nationwide distribution in the states of CA and GA. OUS not provided due to product being manufacture OUS
Derived failure modes
-
Unknown
Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits