BEUDAMED
    FDA Recall Terminated

    RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests) Part Number: 10491448 RAPIDPoint 500 Measurement Cartridge Lactate (250 Tests) Part Number: 10491447 RAPIDPoint 500 Measurement Cartridge Lactate (100 Tests) Part Number:10844813

    Recall: Z-2079-2014 · Initiated May 23, 2014

    Recall

    Recall Number
    Z-2079-2014
    Event Number
    68437
    Firm
    Siemens Healthcare Diagnostics Inc
    FEI Number
    3002637618
    Product Code
    KHP
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    May 23, 2014
    Posted
    July 18, 2014
    Terminated
    June 10, 2015
    Address
    2 Edgewater Drive, Norwood, MA, 02062

    Description

    RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests) Part Number: 10491448 RAPIDPoint 500 Measurement Cartridge Lactate (250 Tests) Part Number: 10491447 RAPIDPoint 500 Measurement Cartridge Lactate (100 Tests) Part Number:10844813

    Reason

    RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters (e.g., Na+, Ca++, K+, Cl-)

    Action

    Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on May 27, 2014 both in the United States and elsewhere for communication with affected customers. This notice informs customers of the issue with the RAPIDPoint 500 Measurement cartridges. Questions contact: Siemens Customer Care Center or your local Siemens technical support representative at 877-229-3711. What steps can be taken to mitigate the issue: " Install a new RAPIDPoint 500 Measurement Cartridge. or " Install a 405 Measurement Cartridge - The RAPIDPoint 405 cartridge is available in four sizes: Since the Lactate parameter is not available on the RAPIDPoint 405 cartridge, however, you will need to arrange to get your lactate results from other instruments in your central laboratory. or " Use an alternative system to obtain your electrolyte values.

    Distribution

    Nationwide Foreign: U.A.E. Albania Austria Australia Bosnia Herzeg. Belgium Bulgaria Bahrain Brazil Canada Switzerland P.R. China Colombia Czech Republic Germany Denmark Algeria Estonia Egypt Spain Finland France United Kingdom Georgia Greece Hong Kong Croatia Hungary Indonesia Ireland Israel India Italy Japan Republic Korea Kuwait Lithuania Luxembourg Latvia Malaysia Mexico Netherlands Norway New Zealand Peru Poland Portugal Qatar Romania Serbia Russian Fed. Saudi Arabia Sweden Singapore Slovenia Turkey Taiwan

    Quantity

    20,507 cartridges