BEUDAMED
    FDA Enforcement Class II Completed

    6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.

    Recall: Z-0521-2021 · Reported December 9, 2020

    Enforcement

    Recall Number
    Z-0521-2021
    Event ID
    86699
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Chromsystems Instruments & Chemicals GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 9, 2020
    Initiation Date
    October 29, 2020
    Classification Date
    December 2, 2020
    Address
    Am Haag 12, N/A, Grafelfing, N/A, N/A, Germany

    Description

    6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.

    Reason

    Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone.

    Code Info

    Order No. 73039, Lot 3219 (expiration 08/01/2021) and Lot 1020 (Expiration 03/01/2022)

    Distribution

    US Nationwide distribution in the states of NC and NY.

    Quantity

    148 package units