BEUDAMED
    FDA Recall Open, Classified

    Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System. The Dimension Vista Magnesium Flex Reagent (MG) method is an In vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma, and urine on the Dimension Vista System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypomagnesemia (abnormally high plasma levels of magnesium).

    Recall: Z-0830-2022 · Initiated January 28, 2022

    Recall

    Recall Number
    Z-0830-2022
    Event Number
    89697
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    JGJ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 28, 2022
    Address
    500 Gbc Dr, Newark, DE, 19702-2466

    Description

    Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System. The Dimension Vista Magnesium Flex Reagent (MG) method is an In vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma, and urine on the Dimension Vista System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypomagnesemia (abnormally high plasma levels of magnesium).

    Reason

    Dimension Vista Magnesium Flex reagent cartridge lots exhibiting imprecision and intermittent Abnormal Assay flags. When this issue occurs, there is a potential for QC failures or erroneous patient results which may lead to repeat and follow-up testing.

    Action

    The firm, Siemens Healthineers, sent "URGENT MEDICAL DEVICE CORRECTION" (VC-22-01.A.US) on 01/28/2022 via Fed Ex to all customers to inform them of the issue and instruct them to discontinue use and discard the affected lots. Complete and return the Field Correction Effectiveness Check Form via email at [email protected] or fax to: (312) 275-7795. At the present time, Siemens has no replacement lots to offer customers. Siemens suggests using an alternate methodology for magnesium until a replacement lot is available. If you received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Remote Services Center or your local Siemens Technical Support Representative. Replacement kits will be provided when a new lot is available. If you have any questions, please contact your Siemens Healthineers Remote Services Center or your local Siemens Healthineers Technical Support Representative.

    Distribution

    Worldwide distribution: US (nationwide) 47 States including: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY) and OUS countries of: Australia, Canada and Netherlands.

    Quantity

    14220 (US 13305, OUS 915)