BEUDAMED
    FDA Recall Open, Classified

    Atellica CI Analyzer. Catalog Numbers: 10947347.

    Recall: Z-0597-2025 · Initiated November 4, 2024

    Recall

    Recall Number
    Z-0597-2025
    Event Number
    95644
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    JJE
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    November 4, 2024
    Posted
    December 4, 2024
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    Atellica CI Analyzer. Catalog Numbers: 10947347.

    Reason

    Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on the Atellica CI Analyzer, potentially leading to the IMT Diluent being empty while still displaying that volume is remaining. In this case Sodium (Na), Potassium (K) and Chloride (Cl) test results may be falsely elevated. Quality Control materials demonstrate the same behavior.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Austria, Bangladesh, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Iraq, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Malaysia, Netherlands, Oman, Pakistan, Paraguay, Peru, Philippines, Portugal, Qatar, Republic Korea, Romania, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom Great Britain, Vietnam.

    Quantity

    559 units