BEUDAMED
    FDA Recall Terminated

    SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler

    Recall: Z-1378-05 · Initiated July 22, 2005

    Recall

    Recall Number
    Z-1378-05
    Event Number
    32756
    Firm
    Cepheid
    FEI Number
    3004530258
    Product Code
    NSR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 22, 2005
    Posted
    August 17, 2005
    Terminated
    April 14, 2006
    Address
    904 E Caribbean Dr, Sunnyvale, CA, 94089-1189

    Description

    SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler

    Reason

    A problem in the software has the potential to be associated with the incorrect reporting of sample results.

    Action

    On 7/22/05, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the corrective action.

    Distribution

    The product was distributed nationally to 94 consignees directly to medical facilities and internationally to 25 consignees via distributors.