BEUDAMED
    FDA Enforcement Class II Ongoing

    Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.

    Recall: Z-1980-2026 · Reported May 6, 2026

    Enforcement

    Recall Number
    Z-1980-2026
    Event ID
    98666
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 6, 2026
    Initiation Date
    March 18, 2026
    Classification Date
    April 28, 2026
    Address
    500 Gbc Dr, Newark, DE, 19702-2466, United States

    Description

    Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.

    Reason

    Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quality control (QC) and patient sample results using lot numbers GA6307 and BA7005 on the Dimension System. This imprecision may lead to erroneously decreased or increased creatinine patient results

    Code Info

    Material Number: 10872079. Model Number: DF33B. UDI: (01)00630414595009(10)GA6307(17)20261103, (01)00630414595009(10)BA7005(17)20270105. Lot Numbers: GA6307, BA7005.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Brazil, Cambodia, Canada, Chile, China, Columbia, Costa Rica, Ecuador, Egypt, Germany, Honduras, India, Indonesia, Korea, Kuwait, Lebanon, Malaysia, Mexico, Nicaragua, Pakistan, Paraguay, Philippines, Qatar, Saudi Arabia, Serbia, Slovenia, South Africa, Sri Lanka, Taiwan, Thailand, U.A.E., Ukraine, Uruguay, Vietnam, Yemen.

    Quantity

    18,080 units