BEUDAMED
    FDA Recall 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 · Initiated September 2, 2020

    Recall

    Recall Number
    Z-0099-2021
    Event Number
    86465
    Firm
    Gentian AS Bjornasveien
    FEI Number
    3006801241
    Product Code
    NDY
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    September 2, 2020
    Terminated
    September 28, 2022
    Address
    5 Moss 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.

    Action

    Gentian AS issued a "Field Safety Notice" letter on September 2, 2020 concerning the removal of the Gentian Cystatin C Calibrator and Calibrator Kit. In addition, to informing consignees about the recall the firm asked consignees to take the following actions: 1. Discontinue use of the affected lots listed in this Field Safety Notice 2. Please inform Gentian of remaining stock of the affected lots numbers given in this Field Safety Notice. 3. Share this notification with other relevant personnel in your organization and affected customers 4. Please sign and return this document by e-mail to confirm that this notification of withdrawal has been received and understood.

    Distribution

    US: MN, VA, KS,

    Quantity

    107 calibrator kits