BEUDAMED
    FDA Recall Terminated

    Dimension Vista Ammonia Flex reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension clinical chemistry system. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as cirrhosis, hepatitis and Reye s syndrome

    Recall: Z-1141-2017 · Initiated December 16, 2016

    Recall

    Recall Number
    Z-1141-2017
    Event Number
    76152
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    JIF
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 16, 2016
    Terminated
    January 9, 2018
    Address
    500 Gbc Dr PO BOX 6101, Ms 514, Newark, DE, 19702-2466

    Description

    Dimension Vista Ammonia Flex reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension clinical chemistry system. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as cirrhosis, hepatitis and Reye s syndrome

    Reason

    Siemens Healthcare Diagnostics has determined that Dimension Vista AMM (K3119) Flex reagent cartridge flex lots 16187BE, 16225BB, 16265AB do not meet the 60-day calibration interval claim due to reagent instability and results may show an Abnormal Assay.

    Action

    Siemens sent an Urgent Field Safety Notice on December 20, 2016, to all customers who were affected by the issue. The letter identified the reason for the correction, the associated risks to health, and actions to be taken by the customer. Customers were instructed to discontinue use of and discard the affected lots, complete and return the Field Correction Effectiveness Check Form attached to the letter. Customers with questions were instructed to contact their Siemens Customer Care Center or their local Siemens technical support representative. For questions regarding this recall call 800441-9250.

    Distribution

    Worldwide Distribution - US (Nationwide) and Internationally to Argentina, Austria, Australia, Bangladesh, Belgium, Brazil, Bosnia Herzegovina. ,Canada, Canary Islands, Chile, China, Colombia, Croatia, Denmark, Ecuador, Egypt, France, Germany, Great Britain, Hong Kong, Hungary Israel ,India, Indonesia, Italy, Lebanon, Malaysia, Mexico, Nicaragua, Netherland, New Zealand, Philippines, Poland, Portugal, Republic of Korea, Saudi Arabia, Serbia, Slovakia, Slovenia, Spain, Sri Lanka, South Africa, Switzerland, Taiwan, Turkey, Uruguay, United.Arab Emirates, Venezuela, Yemen, and Japan.

    Quantity

    8,032 units