BEUDAMED
    FDA Enforcement Class III Terminated

    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.

    Recall: Z-0033-2022 · Reported October 13, 2021

    Enforcement

    Recall Number
    Z-0033-2022
    Event ID
    88680
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sentinel CH SpA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    October 13, 2021
    Initiation Date
    July 29, 2021
    Classification Date
    October 6, 2021
    Termination Date
    July 24, 2023
    Address
    Via Robert Koch 2, Milan, N/A, Italy

    Description

    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.

    Reason

    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.

    Code Info

    Lot 00681Y600

    Distribution

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

    Quantity

    32