BEUDAMED
    FDA Recall Terminated

    Roche brand OMNI 1 Analyzer; catalog numbers GD0315 and GD0315R.

    Recall: Z-0329-04 · Initiated December 29, 2003

    Recall

    Recall Number
    Z-0329-04
    Event Number
    27989
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 29, 2003
    Posted
    July 20, 2004
    Terminated
    February 20, 2004
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche brand OMNI 1 Analyzer; catalog numbers GD0315 and GD0315R.

    Reason

    The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.

    Action

    A recall letter dated 12/29/03 was issued to each customer instructing them not to use the listed sample types.

    Distribution

    United States.