BEUDAMED
    FDA Recall Terminated

    ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866

    Recall: Z-0196-2022 · Initiated September 22, 2021

    Recall

    Recall Number
    Z-0196-2022
    Event Number
    88768
    Firm
    Siemens Healthcare Diagnostics, Inc
    FEI Number
    1219913
    Product Code
    QKP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 22, 2021
    Terminated
    August 2, 2022
    Address
    333 Coney St, East Walpole, MA, 02032-1516

    Description

    ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866

    Reason

    Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.

    Action

    On 9/22/2021, Siemens Healthineers issued Urgent Medical Device Correction notices to all US affected customers by FedEx beginning. The customer distribution included all US customers that have received the Atellica IM and ADVIA Centaur CoV2Ag assays. Actions to be Taken by the Customer - Discontinue use of and discard the kit lots listed in the notice. - Please discuss this letter with your Medical Director. - Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. - To receive credit for discarded product, please complete and return the form provided. If you have received any complaints of illness or adverse events associated with the products listed in the notice, 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.

    Distribution

    US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, ME, NC, NV, NY, OR, PA, PR, VA and VI.

    Quantity

    261 kits