BEUDAMED
    FDA Recall Terminated

    Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Roche Diagnostics Corporation, Indianapolis, IN 46250.

    Recall: Z-0576-2008 · Initiated December 4, 2007

    Recall

    Recall Number
    Z-0576-2008
    Event Number
    45984
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    JJY
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 4, 2007
    Posted
    March 4, 2008
    Terminated
    August 4, 2008
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Roche Diagnostics Corporation, Indianapolis, IN 46250.

    Reason

    Incorrect results: CRP assays may be calculated using incorrect calibration parameters which could result in falsely high or falsely low patient results being reported.

    Action

    Roche Diagnostics contacted the consignee by phone on 12/4/07 and by follow-up letter dated 12/4/07. The user was instructed to discontinue use of two CRP assays on this analyzer. The letter described a workaround and that a new revision of software, due out first quarter 2008, will fix this.

    Distribution

    USA Distribution in the state of Nebraska.

    Quantity

    1