BEUDAMED
    FDA Recall Open, Classified

    ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)

    Recall: Z-2666-2023 · Initiated August 8, 2023

    Recall

    Recall Number
    Z-2666-2023
    Event Number
    92971
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    CDQ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 8, 2023
    Posted
    September 30, 2023
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)

    Reason

    There is a potential for a positive bias on Quality Control (QC) and patient sample results when using some IRON_2 reagent wedge pairs. When the issue occurs, the observed bias will vary wedge to wedge.

    Action

    An Urgent Medical Device Correction notification letter dated 8/8/23 was sent to customers. Actions to be Taken by the Customer Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. Perform the instructions provided in Additional Information. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Additional Information Please complete these instructions with each wedge set in your inventory prior to processing patient samples. 1. Ensure only one R1 and one R2 is onboard the system. 2. Run each level of QC that your laboratory has identified for use with IRON_2 on that reagent wedge set and determine if your QC criteria are met. 3. If acceptance criteria IS met, proceed using the R1/R2 wedge to generate patient results. 4. If the acceptance criteria IS NOT met, discard the reagent wedge set. If you have another set of IRON_2 reagent, repeat steps 1 3 and assess acceptance.

    Distribution

    US Nationwide. Global Distribution

    Quantity

    4966 reagents