FDA-Device2021-10-13Class III
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.
Sentinel CH SpA
Hazard
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.
Sold states
US Nationwide distribution in the states of LA, MD, MN, ND, NY, WV, and Puerto Rico.
Affected count
32
Manufactured in
Via Robert Koch 2, Milan, Italy
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0033-2022Don't want to check this manually?
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