BEUDAMED
    FDA Recall Terminated

    TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, containing HBV Quantitation Standard (HBV QS).

    Recall: Z-0983-05 · Initiated February 14, 2005

    Recall

    Recall Number
    Z-0983-05
    Event Number
    31161
    Firm
    Roche Molecular Systems Inc
    FEI Number
    2243471
    Product Code
    MVU
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 14, 2005
    Posted
    July 13, 2005
    Terminated
    October 3, 2006
    Address
    1080 Us Highway 202 S, Somerville, NJ, 08876-3733

    Description

    TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, containing HBV Quantitation Standard (HBV QS).

    Reason

    Low level of recombinant HIV DNA found in one lot of HBV QS which is a component of one lot of the TaqMan HBV ASR.

    Action

    Notification letter to LabCorp wa sent on 2/14/2005 via FedEx.

    Distribution

    One customers received 14 kits on 1/3/2005. This one customer was LabCorp, 1912 Alexander Drive, Research Triangle Park, NC 27709.

    Quantity

    450 sets