BEUDAMED
    FDA Enforcement Class II Terminated

    GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012, UDI: (01)07090038460092 2. Gentian C E Calibrator Kit, 6 x 1 mL, REF 1051, UDI: (01)07090038460108 3. Gentian C E, BCI Ref: A52763, Cystatin C calibrator Kit, 6 x 1 mL, REF 1051, (01)17090038460037 4. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 8012 (Not distributed in US)

    Recall: Z-0099-2021 · Reported October 21, 2020

    Enforcement

    Recall Number
    Z-0099-2021
    Event ID
    86465
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Gentian AS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 21, 2020
    Initiation Date
    September 2, 2020
    Classification Date
    October 13, 2020
    Termination Date
    September 28, 2022
    Address
    Bjornasveien 5, N/A, Moss, N/A, N/A, Norway

    Description

    GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012, UDI: (01)07090038460092 2. Gentian C E Calibrator Kit, 6 x 1 mL, REF 1051, UDI: (01)07090038460108 3. Gentian C E, BCI Ref: A52763, Cystatin C calibrator Kit, 6 x 1 mL, REF 1051, (01)17090038460037 4. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 8012 (Not distributed in US)

    Reason

    The firm has identified lots of calibrators that have shown to measure incorrect high values over time compared to the assigned values when released for distribution. This could result in higher Cystatin C values measured in patients.

    Code Info

    Lot numbers #s: 1905415,1904404,1904403,1809403

    Distribution

    US: MN, VA, KS,

    Quantity

    107 calibrator kits