BEUDAMED
    FDA Recall Terminated

    Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent.

    Recall: Z-1156-04 · Initiated August 18, 2003

    Recall

    Recall Number
    Z-1156-04
    Event Number
    29114
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    MSS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 18, 2003
    Posted
    July 23, 2004
    Terminated
    August 30, 2004
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent.

    Reason

    Values for ApoB were not properly assigned on the package insert. Customers were not able to recover the analyte within the stated values.

    Quantity

    5275