BEUDAMED
    FDA Recall Terminated

    Dimension Ferritin (FERR) Flex reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on the Dimension RxL clinical chemistry system to quantitatively measure ferritin in human serum and plasma. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis and iron deficiency anemia.

    Recall: Z-2229-2019 · Initiated July 15, 2019

    Recall

    Recall Number
    Z-2229-2019
    Event Number
    83384
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    JMG
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 15, 2019
    Terminated
    August 12, 2021
    Address
    500 Gbc Dr, Newark, DE, 19702-2466

    Description

    Dimension Ferritin (FERR) Flex reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on the Dimension RxL clinical chemistry system to quantitatively measure ferritin in human serum and plasma. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis and iron deficiency anemia.

    Reason

    Negative Bias with Lot EA9227.

    Action

    Siemens sent an Urgent Field Safety Notice letter dated July 2019 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to 1. Review the letter with their Medical Director 2. Discontinue use and discard the kit. 3. Complete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days. send a scanned copy of the completed form via email to or fax this completed form to the Customer Care Center at 312-275-7795. 4. If you have received any complaints of illness or adverse events associated with the product listed in the letter, immediately contact their local Siemens Customer Care Center or their local Siemens Technical Support Representative. 5. Retain this letter with your laboratory records and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.

    Distribution

    Worldwide Distribution AK AR AZ CA CT FL GA IA ID IL IN KS KY LA MD MI MN MO MS MT NC NE NH NJ NY OK OR PR SD TN TX VA VT WA WI

    Quantity

    815 kits