BEUDAMED
    FDA Recall Terminated

    BioTek brand Automated Microplate Reader; model ELx808, Roche catalog number 03145387001.

    Recall: Z-0574-05 · Initiated February 15, 2005

    Recall

    Recall Number
    Z-0574-05
    Event Number
    31146
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    JJQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 15, 2005
    Posted
    March 8, 2005
    Terminated
    May 10, 2006
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    BioTek brand Automated Microplate Reader; model ELx808, Roche catalog number 03145387001.

    Reason

    The parameters loaded in the analyzer for the hepatitis C virus do not match those in the package insert, and patient results may be reported out as false positives or false negatives.

    Action

    Recall letters dated 2/15/05 are being sent to each consignee instructing them to discontinue use of pre-programmed HCV parameters with the Amplicor heatitis C virus test and that previous test results within a specific range be reviewed by a physician.

    Distribution

    Nationwide and Canada.