BEUDAMED
    FDA Recall Terminated

    MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001.

    Recall: Z-1371-04 · Initiated August 6, 2004

    Recall

    Recall Number
    Z-1371-04
    Event Number
    29671
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    NPQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 6, 2004
    Posted
    August 17, 2004
    Terminated
    October 5, 2005
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001.

    Reason

    A hardware/software problem will result in low elution volumes and bias sample results for various protocols.

    Action

    Consignees were notified via recall letter dated 8/6/04.

    Distribution

    United States.

    Quantity

    192