Sentinel CH SpA recalls Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of th…

Recall date

July 29, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0033-2022

FDA classification

Class III

Brand / firm

Sentinel CH SpA

Sold / distributed

US Nationwide distribution in the states of LA, MD, MN, ND, NY, WV, and Puerto Rico.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.