BEUDAMED
    FDA Recall Open, Classified

    Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.

    Recall: Z-1980-2026 · Initiated March 18, 2026

    Recall

    Recall Number
    Z-1980-2026
    Event Number
    98666
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    CGX
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 18, 2026
    Posted
    April 28, 2026
    Address
    500 Gbc Dr, Newark, DE, 19702-2466

    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

    Action

    Siemens Healthineers notified consignees on about 03/18/2026 via letter. Consignees were notified of the issue, the hazard involved and instructed to immediately discontinue use of and discard the affected kit lots, each facility should review the recall notification with their Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable, and review inventory to determine the laboratory's replacement needs and communicate that with Siemens Healthineers. Consignees were also instructed to complete and return the Field Correction Effectiveness Check Form provided and retain the letter with laboratory records and forward it to anyone how may have received or used the affected product.

    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