BEUDAMED
    FDA Recall Terminated

    Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles, lot number: 454778 Kit Catalog Number: 112219 SMN: 10310026 Intended Use: In vitro diagnostic use. Acid Regent is a component of the ADVIA Centaur and ADVIA Centaur XP instruments

    Recall: Z-1927-2014 · Initiated June 2, 2014

    Recall

    Recall Number
    Z-1927-2014
    Event Number
    68537
    Firm
    Siemens Healthcare Diagnostics, Inc
    FEI Number
    1219913
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    June 2, 2014
    Posted
    June 26, 2014
    Terminated
    February 5, 2015
    Address
    333 Coney St, East Walpole, MA, 02032-1516

    Description

    Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles, lot number: 454778 Kit Catalog Number: 112219 SMN: 10310026 Intended Use: In vitro diagnostic use. Acid Regent is a component of the ADVIA Centaur and ADVIA Centaur XP instruments

    Reason

    Swollen acid bottles due to a trace metal contamination in the Acid Reagent bottles

    Action

    Siemens Healthcare Diagnostics issued Urgent Medical Device Recall (UMDR) to customers in the United States on June 02, 2014 and a Urgent Field Safety Notice (UFSN) issued outside the United States on June 02, 2014. These notices inform the customer of the potential for swollen acid bottles due to confirmed metal contamination. Customers with alternative lots in inventory were instructed to transition to the alternative lot upon receipt of the communication. Customers without an alternative lot of acid in inventory were informed that Siemens proactively shipped an alternative lot to their laboratory and they should transition to that lot upon its receipt. Siemens also informed customers without an alternative lot that they may continue to run and report patient results using the affected lot of acid. Questions contact your Siemens Customer Care Center or your local Siemens technical support representative.

    Distribution

    Worldwide Distribution - US Nationwide and the countries of Canada, Argentina, China, Colombia, Korea, Malyasia, New Zealand, Mexico, Guatemala, and Singapore.

    Quantity

    3,839 kits