Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.
Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instrument to generate a warning that calibrators are incorrectly loaded and calibration will not be completed successfully.
US Nationwide distribution in the states of LA, MD, MN, ND, NY, WV, and Puerto Rico.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0033-2022