BEUDAMED
    FDA Recall Terminated

    Cepheid brand Xpert MRSA/SA-BC US-IVD, an In-vitro diagnostic test kit, Catalog Numbers: GXMRSA/SA-BC-10, Lots Affected: 2803 and 3001;

    Recall: Z-0453-2012 · Initiated November 17, 2011

    Recall

    Recall Number
    Z-0453-2012
    Event Number
    60481
    Firm
    Cepheid
    FEI Number
    3004530258
    Product Code
    NQX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 17, 2011
    Posted
    January 11, 2012
    Terminated
    January 9, 2012
    Address
    904 E Caribbean Dr, Sunnyvale, CA, 94089-1189

    Description

    Cepheid brand Xpert MRSA/SA-BC US-IVD, an In-vitro diagnostic test kit, Catalog Numbers: GXMRSA/SA-BC-10, Lots Affected: 2803 and 3001;

    Reason

    Cepheid has received reports from some of its customers regarding higher than desired (>5%) rates of invalid results when using lot numbers 2803 and 3001 of the Xpert MRSA/SA BC (blood culture) product.

    Action

    On 11/17/11, Cepheid issued letters via mail to all its direct consignees, informing them of the affected products and providing instructions on the recall.

    Distribution

    Product was released for distribution in US.

    Quantity

    1289