BEUDAMED
    FDA Recall Open, Classified

    ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941

    Recall: Z-0101-2021 · Initiated September 22, 2020

    Recall

    Recall Number
    Z-0101-2021
    Event Number
    86504
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    JIT
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    September 22, 2020
    Posted
    October 13, 2020
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941

    Reason

    Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic therapy. Positively biased fructosamine results may prompt changes in glucose management that may affect glycemia. In extreme situations, more aggressive management of glycemia may occur and contribute to hypoglycemia.

    Action

    Siemens Urgent Medical Device Recall (ACHC20-18.A.US.CHC) distributed to customers on 9/22/20, in the United States and an Urgent Field Safety Notice (ACHC20-18.A.OUS.CHC) was distributed to customers outside the United States who have received ADVIA Chemistry Fructosamine in-date reagent lots. For Atellica, an Urgent Medical Device Recall (ACHC20-18.A.US) was distributed to l customers in the United States and an Urgent Field Safety Notice (ACHC20-1.OUS) was distributed to all customers outside the United States who have received Atellica CH in date reagent lots. These letters instruct the customers to: Perform the following actions on the ADVIA Chemistry System 1. Enter the Real-time correction factor in the Analytical Parameters (Chemistry) window. 2. Once the Real-time correction factor has been configured, update QC ranges as described above in the FRUC QC Definition following your laboratory procedures. 3. Update the reference range following your laboratory procedures. 4. Perform a FRUC calibration and process QC. 5. Perform a system back-up. Complete and return the Field Correction Effectiveness Check attached to this letter within 30 days. " Review this letter with your Medical Director. " 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

    Distribution

    CA, DE, MD, NC, NJ, NY, PA Foreign: Argentina¿¿¿¿¿¿ Australia¿¿¿¿¿¿ Brazil¿¿¿¿ Canada¿¿¿¿¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ Netherlands¿¿¿¿ P.R.¿China¿¿¿¿¿ Paraguay¿¿¿¿¿¿¿ Slovakia¿¿¿¿¿¿¿ Turkey¿¿¿¿¿¿¿¿¿ United¿Kingdom¿ Vietnam¿¿¿¿¿¿¿¿

    Quantity

    US: 23 units; OUS: 204 units