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Sentinel CH SpA recalls Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the
Recalled October 13, 2021 · FDA recall Z-0033-2022 · 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. · FDA Class III
Units
32
Sold at
US Nationwide distribution in the states of LA, MD, MN, ND, NY, WV, and Puerto Rico.
Description
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.
Product
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.
Manufacturer(s)
Sentinel CH SpA
Made in
Italy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →