BEUDAMED
    FDA Recall Terminated

    MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001.

    Recall: Z-0297-05 · Initiated November 5, 2004

    Recall

    Recall Number
    Z-0297-05
    Event Number
    30483
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    NPQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 5, 2004
    Posted
    December 8, 2004
    Terminated
    August 29, 2005
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001.

    Reason

    Test results may be adversely affected by software shutting down the cooling blocks in systems with software version 3.09.

    Action

    Consignees were notified via letter dated 11/5/04, which provides the user with a workaround.

    Distribution

    Nationwide.

    Quantity

    65